Committee Report

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Union Calendar No. 304
106th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 106-556
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THE DEPARTMENT OF DEFENSE ANTHRAX VACCINE IMMUNIZATION PROGRAM:
UNPROVEN FORCE PROTECTION
_______
April 3, 2000.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Burton, from the Committee on Government Reform submitted the
following
FOURTH REPORT
On March 9, 2000, the Committee on Government Reform
approved and adopted a report entitled, ``The Department of
Defense Anthrax Vaccine Immunization Program: Unproven Force
Protection.'' The chairman was directed to transmit a copy to
the Speaker of the House.
I. Summary
Responding to service members' complaints of program
insensitivity to adverse health effects, inadequate medical
recordkeeping, and heavy-handed program operation, the
Subcommittee on National Security, Veterans Affairs, and
International Relations initiated an oversight investigation
into the design and implementation of the Department of Defense
[DOD] force-wide, mandatory Anthrax Vaccine Immunization
Program [AVIP]. Because the anthrax vaccine is still being
studied as a potential causative or contributing factor in Gulf
war veterans' illnesses,\1\ the subcommittee measured the
program against this standard: Any expanded use of the same
vaccine should be undertaken only with the greatest care and
only to the extent necessary.
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\1\ Public Law 105-277, title XVI, sec. 1603(d).
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As currently designed and implemented, the anthrax vaccine
program fails on both counts. The AVIP lacks a consistent
standard of care and is designed to reach far beyond those at
risk.
Based on the testimonial and documentary record,\2\ the
subcommittee finds the AVIP a well-intentioned but overwrought
response to the threat of anthrax as a biological weapon.
Against the so-called ``asymmetric'' threats to U.S.
conventional military superiority posed by a growing range of
chemical and biological weapons, the anthrax vaccine program
represents a medical maginot line, a fixed fortification
protecting against attack from only one direction.
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\2\ In response to the subcommittee's investigative requests, DOD
provided more than 100,000 pages of documentary and electronic records
on the anthrax vaccine program from 1991 to the present. Five
subcommittee hearings were held in 1999, encompassing 20 hours of
testimony from 46 witnesses. The full Committee on Government Reform
also heard testimony on the subject of vaccines for military defense on
Oct. 12, 1999.
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Unrealistic Program
As a mandatory, force-wide countermeasure to the real
threat of weaponized anthrax on the battlefield, the vaccine
effort is unrealistic. It expands and distorts the use of
invasive, dated medical technology to address perceived
weaknesses in detection technology and external physical
protection against biological attack. Born of a post-Gulf war
panic over apparent weaknesses in chemical and biological [CB]
warfare defenses, the AVIP is an unmanageably broad military
undertaking built on a dangerously narrow scientific and
medical foundation.
At best, the vaccine provides some measure of protection to
most who receive it. Just how much protection is acquired, by
whom, for how long, and against what level of challenge are
questions DOD answers with an excess of faith but a paucity of
science.
Many members of the armed forces do not share that faith.
They do not believe merely suggestive evidence of vaccine
efficacy outweighs their concerns over the lack of evidence of
long term vaccine safety. Nor do they trust DOD has learned the
lessons of past military medical mistakes: atomic testing,
Agent Orange, Persian Gulf war drugs, and vaccines. Heavy
handed, one-sided informational materials only fuel suspicions
the program understates adverse reaction risks in order to
magnify the relative, admittedly marginal, benefits of the
vaccine.
As a military operation, the AVIP rests on weak conceptual
and logistical footing. It suffers from poor planning,
inflexible execution, and over-extended supply lines. As a
health care effort, the AVIP compromises the practice of
medicine to achieve military objectives.
The decision to use the 1950's era vaccine, which requires
an elaborate inoculation regime of six shots over 18 months,
presents daunting, perhaps insurmountable, logistical
challenges to reach a force of 2.4 million active duty and
reserve component members. Research to support a shorter, more
manageable inoculation regimen was not completed before the
AVIP was launched. Development of a purer, potentially less
reactogenic anthrax vaccine using recombinant technologies was
not pursued aggressively.
Unstable Supply
The sole-source procurement strategy leaves the program
vulnerable to supply shortages and price increases. Because
Food and Drug Administration [FDA] regulations require a
dedicated production facility for spore-based biologics, other
pharmaceutical firms will not commit the time and capital
needed to manufacture an old vaccine for a very limited market.
As a result, DOD and the sole vaccine maker are locked in a
mutually dependent relationship.
The manufacturer, struggling to reopen a plant with a
checkered regulatory history, clings to a captive customer.
Threats to stop production render DOD unable to resist demands
for extraordinary financial relief and pressure to permit the
use of publicly funded improvements to monopolize the private
domestic and foreign markets as well.
Uncertain Safety
Incurious reliance on FDA approval of the vaccine as
``safe'' for occupational exposure blinds the program to
potential adverse reaction trends in a vastly expanded,
demographically diverse population of vaccine recipients.
Adverse events following vaccination are reported by women at
twice the rate among men. The vaccine may be as safe as many
other approved products, but valid data to support, or refute,
that proposition will not come from the AVIP. Preposterously
low adverse report rates generated by DOD point to a program
far more concerned with public relations than effective force
protection or the practice of medicine.
The AVIP raises an ominous question: Who protects the force
from ill-conceived force protection? The anthrax vaccine effort
is designated a ``commander's program,'' not a medical program,
so DOD doctors appear unable to act as advocates for individual
patients in the face of command pressure to meet force-wide
inoculation levels. FDA regulations reach only the vaccine
producer, the BioPort Corp., not the activities of the vaccine
purveyor, the Pentagon, although for purposes of the AVIP the
distinction is meaningless.
Untested Efficacy
Administration of the anthrax vaccine for mass prophylaxis
against biological warfare should be considered an off-label
use of the product to treat an indication for which it is not
explicitly licensed. DOD's operational use of a standard of
``functional protection'' after three inoculations constitutes
a de facto alteration of the approved six shot regimen. Both
the new indication and the new schedule should be undertaken
only pursuant to FDA regulations governing clinical trials of
investigational new drugs [IND].
Under supervision of the FDA and an Institutional Review
Board [IRB], DOD would be required to inform vaccine recipients
adequately, obtain informed consent, and gather data on vaccine
safety consistently. If necessary, DOD could request the
President waive the informed consent requirement for certain
deployed personnel under the statute, regulation, and Executive
order that provide far greater protections to service members
than the process used for similar waivers during the Gulf
war.\3\
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\3\ 10 U.S.C. 1107(f); 21 CFR Part 50; Executive Order No. 13139 of
Sept. 30, 1999.
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Findings in Brief
1. The AVIP is a well-intentioned but over-broad response
to the anthrax threat. It represents a doctrinal departure
overemphasizing the role of medical intervention in force
protection.
2. The AVIP is vulnerable to supply shortages and price
increases. The sole-source procurement of a vaccine that
requires a dedicated production facility leaves DOD captive to
old technology and a single, untested company. Research and
development on a second-generation, recombinant vaccine would
allow others to compete.
3. The AVIP is logistically too complex to succeed.
Adherence to the rigid schedule of six inoculations over 18
months for 2.4 million members of a mobile force is unlikely,
particularly in reserve components. Using an artificial
standard that counts only shots more than 30 days overdue, DOD
tolerates serious deviations from the Food and Drug
Administration [FDA] approved schedule.
4. Safety of the vaccine is not being monitored adequately.
The program is predisposed to ignore or understate potential
safety problems due to reliance on a passive adverse event
surveillance system and DOD institutional resistance to
associating health effects with the vaccine.
5. Efficacy of the vaccine against biological warfare is
uncertain. The vaccine was approved for protection against
cutaneous (under the skin) infection in an occupational
setting, not for use as mass protection against weaponized,
aerosolized anthrax.
Recommendations in Brief
1. The force-wide, mandatory AVIP should be suspended until
DOD obtains approval for use of an improved vaccine. To
accomplish this:
2. DOD should accelerate research and testing on a
second-generation, recombinant anthrax vaccine; and,
3. DOD should pursue testing of the safety and
efficacy of a shorter anthrax inoculation regimen; and,
4. DOD should enroll all anthrax vaccine recipients
in a comprehensive clinical evaluation and treatment
program for long term study.
5. While an improved vaccine is being developed, use of the
current anthrax vaccine for force protection against biological
warfare should be considered experimental and undertaken only
pursuant to FDA regulations governing investigational testing
for a new indication.
II. Background
The Program
On December 15, 1997, after what DOD described as ``a
detailed, deliberative process'' spanning almost 4 years,\4\
Secretary of Defense William S. Cohen announced a program to
immunize all active duty personnel against anthrax, a bacterial
disease that in spore form can be used as a biological weapon.
The effort is called the Anthrax Vaccine Immunization Program
[AVIP].\5\
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\4\ Anthrax Immunization Program, 106th Cong., 1st sess., p. 8
(1999) (Subcommittee on National Security, Veterans Affairs, and
International Relations hearing of Mar. 24, 1999, No. 106-17)
[hereinafter ``NSVAIR anthrax hearing (I)''] (prepared statement of Dr.
Sue Bailey).
\5\ DOD media release, ``Defense Department to Start Immunizing
Troops Against Anthrax,'' No. 679-97, Dec. 15, 1997.
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The program was designed to be implemented in three
phases:\6\
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\6\ AVIP briefing slides (in subcommittee files).
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Phase I (3/98-1/00) forces assigned or rotating to
high threat areas 400,000
Phase II (1/00-1/04) early deploying forces into high
threat areas 1,000,000
Phase III (10/02-9/06) remainder of the total force,
boosters, et cetera 1,000,000
The AVIP is a medical force protection effort undertaken by
DOD pursuant to a 1993 policy calling for immunizations
``against validated biological warfare threat agents, for which
suitable vaccines are available, in sufficient time to develop
immunity before deployment to high-threat areas . . .'' \7\
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\7\ DOD Directive 6205.3, ``DOD Immunization Program for Biological
Warfare Defense.'' Nov. 26, 1993. Other elements of force protection
include intelligence about threats, detection capability, physical
protection (suits, masks, et cetera), post-exposure treatment with
antisera and antibiotics, and strategic deterrence. In the Gulf war, up
to 150,000 U.S. service personnel received one or two doses of the
anthrax vaccine along with other immunizations and medications. Due to
poor or non-existent recordkeeping, however, DOD is unable to conduct a
systematic follow-up on the health effects, if any, of the Gulf war
vaccines.
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According to the DOD news release announcing the vaccine
program, ``After a three year study, Secretary of Defense
William S. Cohen concluded that the vaccination is the safest
way to protect highly mobile U.S. military forces against a
potential threat that is 99 percent lethal to unprotected
individuals.'' \8\ Cohen added, ``To be effective, medical
force protection must be comprehensive, well documented, and
consistent. I have instructed the military to put such a
program in place.'' \9\
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\8\ See supra note 5, p. 1.
\9\ Ibid.
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Accordingly, Secretary Cohen set four conditions on the
start of vaccinations:
1) supplemental testing to assure sterility, safety,
potency, and purity of the vaccine stockpile;
2) implementation of a system for fully tracking
anthrax immunizations;
3) approval of operational plans to administer the
vaccine and communications plans to inform military
personnel; and
4) review of medical aspects of the program by an
independent expert.\10\
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\10\ Ibid.
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In 1998, supplemental testing of the anthrax vaccine
stockpile began.\11\ An elaborate interim recordkeeping and
tracking system was designed to combine vaccination data from
the three military services into an existing central data base,
the Defense Enrollment Eligibility Reporting System
[DEERS].\12\ A more efficient, centralized immunization records
system is under development.\13\ Communication plans were
approved centered around a ``tri-fold'' brochure to be given to
service personnel.\14\ An anthrax vaccine website was also
created.\15\ A physician reviewed the AVIP program plans.\16\
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\11\ Letter from Anthony M. Lutrell, vice president, Quality
Assurance, BioPort Corp., to Dr. Michael Gilbreath, Joint Program
Office for Biological Defense, DOD, Jan. 8, 1999 (in subcommittee
files).
\12\ Major William Terry, ``Tracking Troops' Anthrax Shots,'' (with
charts), ArmyLINK News, March 1999.
\13\ Ibid.
\14\ Department of Defense, AVIP tri-fold brochure, ``What Every
Service Member Should Know About Anthrax'' (undated) (in subcommittee
files).
\15\ Department of Defense website on Anthrax Vaccination
Immunization Program, http://www.anthrax.osd.mil.
\16\ Letter from Dr. Gerard N. Burrow, Special Advisor to the
President for Health Affairs, David Page Smith Professor of Medicine,
Professor of Obstetrics and Gynecology, Yale University School of
Medicine, to DOD Undersecretary Rudy de Leon, Feb. 19, 1998 (in
subcommittee files).
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In March 1998, at the request of the regional commander,
48,000 troops assigned to the Persian Gulf area began the
vaccination series. On May 18, 1998, Secretary Cohen pronounced
the four conditions fulfilled and approved the total force
program, which began in September with troops in Korea.\17\
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\17\ Steve Bowman, Department of Defense Anthrax Vaccination
Program (98-873F), Congressional Research Service report (updated),
Oct. 28, 1998, p. 2.
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DOD cited several factors to support the conclusion the
anthrax vaccine is both safe for widespread use and effective
against the most likely anthrax threat:
1) FDA approval and monitoring of the vaccine;
2) vaccine usage since approval;
3) assured production capacity;
4) independent medical review;
5) supplemental vaccine testing; and,
6) vaccine tests in animals.\18\
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\18\ Prepared statement of Dr. Sue Bailey, Assistant Secretary for
Health Affairs, DOD, NSVAIR anthrax hearing (I), p. 9 .
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FDA Approval of the Vaccine
The AVIP uses the only anthrax vaccine licensed for
manufacture in the United States. Anthrax Vaccine Absorbed
[AVA] was approved as safe in 1970 based on animal studies and
one study of wool workers exposed to indeterminate levels of
cutaneous (through skin) and airborne anthrax spores. The
disease primarily infects grazing animals and the vaccine has
been used since 1970 by some veterinarians, livestock workers,
and researchers at risk from exposure. The approved
immunization process requires a fixed schedule of six
injections over 18 months and an annual booster. The vaccine
does not contain live anthrax bacteria, but challenges the
immune system to mount a response to filtered elements of the
killed bacteria absorbed into an adjuvant.\19\
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\19\ The FDA-approved immunization schedule: Day 1, 2 weeks, 4
weeks, 6 weeks, 6 months, 12 months, and 18 months. An adjuvant is an
ingredient that modifies or enhances the effectiveness of the drug or
treatment.
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Subsequent FDA review of the studies in 1985 concluded the
vaccine was safe, ``fairly well tolerated,'' and effective
against cutaneous anthrax, but that data from both human and
animal tests was insufficient to support a finding of efficacy
with regard to airborne exposure.\20\ In analyzing the benefit/
risk ratio of classifying the old vaccine as compliant under
new FDA standards, the expert panel concluded, ``This vaccine
is recommended for a limited, high-risk of exposure population
along with other industrial safety measures designed to
minimize contact with potentially contaminated material. The
benefit-to-risk assessment is satisfactory under the prevailing
circumstances of use.'' \21\ (Emphasis added).
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\20\ Federal Register, 21 CFR Part 610, Dec. 13, 1985, p. 51058.
\21\ Ibid.
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The sole producer of the vaccine is the Michigan Biologics
Products Institute [MBPI], formerly the Michigan Public Health
Department. Since licensure in 1970, FDA monitoring of the
vaccine consisted of collecting adverse reaction data and
conducting intermittent manufacturing plant inspections.
While detailed information on inspection activities prior
to 1990 is not readily available, FDA regulatory scrutiny of
the manufacturer has been increasing since then. The Lansing,
MI, facility has been cited repeatedly by the FDA for quality
control deficiencies and ``numerous significant deviations from
the Federal Food, Drug, and Cosmetic Act, FDA's regulations and
the standards in MBPI's license.'' \22\ In March 1997, the FDA
warned MBPI that steps would be taken to revoke production
licenses, including anthrax vaccine, unless immediate actions
were taken to correct longstanding deficiencies.\23\ In March
1998, the plant was closed for $1.8 million in renovations and
a $15 million expansion funded by DOD.\24\ Vaccine production
resumed in May 1999, but neither the renovated facility nor any
newly produced vaccine lots have been approved by the FDA.\25\
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\22\ DOD's Mandatory Anthrax Vaccine Immunization Program for
Military Personnel, 106th Cong., 1st sess., p. 58 (1999) (Subcommittee
on National Security, Veterans Affairs, and International Relations
hearing of Apr. 29, 1999, No. 106-26) [hereinafter ``NSVAIR anthrax
hearing (II)''] (testimony of Dr. Kathryn Zoon, Director, FDA Center
for Biologics Evaluation and Research).
\23\ Center for Biologics Evaluation and Research, FDA, ``FDA Warns
Michigan Biological Products Institute of Intention to Revoke
Licenses,'' No. D0382, Mar. 11, 1997.
\24\ Department of Defense's Sole-Source Anthrax Vaccine
Procurement, 106th Cong., 1st sess., p. 8 (1999) (National Security,
Veterans Affairs, and International Relations Subcommittee hearing of
June 30, 1999) [hereinafter ``NSVAIR anthrax hearing (III)'']
(testimony of Louis J. Rodrigues, Director, Defense Acquisitions
Issues, National Security and International Affairs Division, U.S.
General Accounting Office).
\25\ DOD news briefing, Monday, Dec. 13, 1999 (available at http://
www.defenselink.mil and in subcommittee files).
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Deviations from good manufacturing practices can affect
vaccine safety and effectiveness. FDA will not permit the
release of vaccines not documented to meet approved potency,
sterility, and stability levels. Based on concerns over the
impact of production process errors on vaccine quality, BioPort
quarantined 11 lots of anthrax vaccine. Additional lots are
being held pending resolution of questions about potency
testing that arose during the supplemental review.\26\
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\26\ ``Medical Readiness: DOD Faces Challenges in Implementing Its
Anthrax Vaccine Immunization Program,'' (GAO/NSIAD-00-36) U.S. General
Accounting Office, Oct. 22, 1999, p. 13. See also, Department of
Defense Joint Program Office--Biological Defense, ``Investigation of
Supplemental Potency Testing'' JPO-0855 (undated) (in subcommittee
files). See also, prepared statement of BG Eddie Cain, Joint Program
Manager, Joint Program Office for Biological Defense, NSVAIR anthrax
hearing (II), p. 68.
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Under FDA regulations, stockpiled lots must be tested for
potency at predetermined intervals. Potency tests are done
using guinea pigs by comparing the survival rates of animals
vaccinated with the test lot(s) against those vaccinated with a
previously manufactured control or ``reference'' lot. Potency
test failures during the DOD supplemental testing program have
raised questions regarding the validity of test procedures and
the selection of reference lots.\27\
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\27\ Letter from Joseph S. Little, Contracting Officer, Department
of the Army to Fuad El-Hibri, BioPort Corp., Sept. 23, 19989 (in
subcommittee files).
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Assured Production Capacity
MPBI was purchased in September 1998 by the BioPort Corp.,
a new company formed by private investors, including former
Joint Chiefs Chairman Adm. William J. Crowe. The next month
BioPort was awarded a DOD contract valued at $29 million to
produce anthrax vaccine for the AVIP.\28\ The contract (DAMD17-
98-C 8052) provides for a 1 year base period and 2 option
years. The contract provides for a full-term, fixed price,
fixed annual quantity because ``the Government currently
requires all the AVA [anthrax vaccine absorbed] that BioPort
can produce.'' Under the agreement, BioPort will receive
progress payments at various stages of the anthrax vaccine
production process.
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\28\ Department of Defense (1998) Award/Contract: U.S. Army Medical
Research ACQ Activity--BioPort Corp., DAMD17-98-C-8052, Sept. 17, 1998.
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On August 5, 1999, DOD announced the contract had been
``restructured'' to increase the price by $24.1 million,
including $18.7 million of advance payments.\29\
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\29\ Department of Defense media release, ``DOD Announces Contract
Restructuring,'' Aug. 5, 1999 (in subcommittee files).
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This contract, and earlier contracts with MPBI and MDPH,
were accompanied by a justification and authorization for other
than full and open competition (sole source). The sole source
procurement was authorized because ``Michigan Biologics
Products Institute [MBPI] is the only organization in the U.S.
with a Food and Drug Administration [FDA] license to
manufacture AVA'' and ``[d]ue to the time and expense required
to produce a licenced product, investing in alternate
manufacturers is not considered to be an effective way of
meeting the Government's requirements.'' \30\ DOD also
indemnified MBPI/BioPort against liability arising from ``the
risks of adverse reactions, or the failure to confer immunity
against anthrax . . .'' \31\
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\30\ Joseph S. Little ``Justification and Approval for Other than
Full and Open Competition,'' Anthrax Vaccine Absorbed, DAMD17-97-0014
(JPO 0836) May 20, 1997 (in subcommittee files).
\31\ Memorandum of decision, Secretary of the Army Louis Caldera,
Authority Under Public Law 85-804 to include an indemnification clause
in contract DAMD 17-91-C-1139 with Michigan Biologic Products
Institute, Sept. 3, 1998 (in subcommittee files).
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Potential liability resulting from adverse events was a
major issue for the anthrax vaccine manufacturer even when the
vaccine was used by only a few hundred people each year. In
1986, Secretary of the Army John Marsh, Jr., authorized
indemnification of the State of Michigan Department of Public
Health, which would not provide the vaccine without
indemnification due to ``the possibility that persons
vaccinated may develop anaphylaxis or some unforeseen reaction
of serious consequences, including death.'' \32\
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\32\ Memorandum of decision, Secretary of the Army John O. Marsh,
authority under 50 U.S.C. 1431-1435 (Public Law 85-804) to include an
indemnification clause in contracts or purchase orders with the State
of Michigan, Feb. 27, 1986 (in subcommittee files).
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In 1992, Secretary of the Army Togo West, Jr., approved a
request to indemnify the anthrax vaccine manufacturer, the
Michigan Biologics Product Institute [MBPI], against all
liability arising from:
the unusually hazardous risks associated with
potentially severe adverse reactions and the potential
lack of efficacy of the AVA. These concerns stem from:
a) the limited use of the vaccine to date, i.e., tests
prior to approval of the vaccine by the Food and Drug
Administration are on too small a scale to permit
accurate assessment of types and severity of adverse
reactions (only widespread use can provide this
assessment); and b) insufficient experience in mass
immunization programs to truly evaluate the efficacy of
the vaccine. Moreover, there is no way to predict
whether the pathogen against which the vaccine may be
used will be sufficiently similar to the pathogen used
in tests to ensure vaccine efficacy.\33\ (Emphasis
added).
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\33\ Memorandum of decision, Secretary of the Army Togo West, Jr.,
authority under Public Law 85-804 to include an indemnification clause
in contract DAMD17-91-C-1139 with the Michigan Biologic Products
Institute [undated] (in subcommittee files).
In 1998, Secretary of the Army Louis Caldera again
authorized indemnification of MBPI because ``the size of the
proposed vaccination program may reveal unforwarned
idiosyncratic adverse reactions.'' \34\ The contracting officer
justified the later indemnification request, in part, because,
``Since 1990, approximately 600,000 doses have been issued from
MBPI's stockpile. The limited use of AVA to date versus the
large number of doses that are being stockpiled and subject to
use may expand the data base to a point where the statistical
significance of a predicted adverse reaction may become a
reality.'' \35\
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\34\ See supra note 31.
\35\ Joseph S. Little, Contracting Officer, ``Contracting Officer's
Request for Authorization for Indemnification Under Authority of Public
Law 85-804,'' Oct. 8, 1997, p. 3 (in subcommittee files).
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Following the Gulf war, and prior to adoption of the DOD
immunization policy in 1993, and the mandated AVIP in 1998,
Pentagon officials considered and rejected alternative anthrax
vaccine production sites.\36\ Instead, an acquisition strategy
was adopted focusing solely on the MBPI/BioPort vaccine.\37\
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\36\ BG Eddie Cain, ``Procurement of the Anthrax Vaccine-Single
Source Versus Additional Site,'' DOD information paper, JPO 0920, Oct.
19, 1998 (in subcommittee files).
\37\ BG John C. Doesberg, ``Acquisition Strategy for the
Procurement of Anthrax Vaccine Adsorbed,'' Joint Program Office for
Biological Defense, JPO 0120, Feb. 1, 1997 (in subcommittee files).
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Vaccine Usage and Safety
DOD literature says the anthrax vaccine ``has been safely
and routinely administered in the United States to
veterinarians, laboratory workers, and livestock handlers for
more than 25 years.'' \38\ Testimony at the March 24 hearing
indicated between 100 and 300 civilians may receive the vaccine
each year. Since approval, and prior to the AVIP, fewer than
68,000 doses had been distributed apart from stocks used in
Operation Desert Storm.\39\
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\38\ See supra note 14.
\39\ Prepared statement of Dr. Kathryn Zoon, Director, FDA Center
for Biologics Evaluation and Research, NSVAIR anthrax hearing (II), pp.
52-53.
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As with any vaccine, anthrax inoculation can cause adverse
health events in some individuals, ranging from soreness or
swelling at the injection site (local reactions) to fevers,
chills, muscle aches, and anaphylaxis \40\ (systemic
reactions). Local reaction may be mild, moderate, or severe
enough to require medical attention. Systemic reactions are
generally considered clinically more significant. Reactions may
increase in severity after successive injections.\41\
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\40\ Anaphylaxis is one form of hypersensitivity to a drug or
antigen. Anaphylactic shock is an often severe, sometimes fatal,
physical reaction characterized by respiratory symptoms, fainting,
swelling, and itching.
\41\ Michigan Biologic Products Institute, ``Anthrax Vaccine
Absorbed: How Supplied, References, Description, Clinical Pharmacology,
Indications and Usage, Contraindications, Warnings, Precautions,
Adverse Reactions, Dosage and Administration,'' FDA License No. 99,
Rev. February 1998 (in subcommittee files).
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The AVA has been described as a relatively crude,
imprecisely characterized vaccine, and estimates of reaction
rates vary widely.\42\ According to the FDA-approved AVA
product labeling, 30 percent of vaccine recipients can be
expected to suffer mild local reactions, 4 percent will incur
moderate local reactions and less than 0.2 percent will
experience systemic reactions.\43\ In 1994 and 1995, DOD
considered the need for a new anthrax vaccine ``based on the
reactogenicity of the current vaccine.'' \44\
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\42\ Phillip Brachman and Arthur Friedlander, Vaccines, 2d ed., pp.
729-739, Philadelphia, WB Saunders (1994).
\43\ See supra note 41.
\44\ LTC George W. Anderson, Jr., memorandum ``Minutes of the FDA
meeting of May 5, 1994 Concerning Production and Purification of PA
from Delta Stern-1 (pPa102) CR4,'' U.S. Army Medical Research Institute
on Infectious Diseases, May 19, 1994 (in subcommittee files).
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To avoid adverse reactions, the vaccine should not be given
to those who experienced a severe reaction to a previous dose
or to those with acute respiratory disease or an active
infection. Immune compromised persons (i.e., HIV infected) may
not respond to the vaccine. It is not recommended for pregnant
women or for those under 18 or over 65 years of age.\45\
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\45\ See supra note 41.
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The Army Anthrax Vaccine Immunization Plan directs medical
personnel to report severe adverse reactions (resulting in
hospitalization or more than 24 hours lost from duty) through
the Vaccine Adverse Events Reporting System [VAERS]
administered by the Department of Health and Human Services
[HHS].\46\ Within HHS, VAERS is a joint project of the Centers
for Disease Control [CDC] and the Food and Drug Administration
[FDA].\47\ VAERS guidance recommends recording any clinically
significant symptoms occurring subsequent to vaccine
administration, whether or not a causal relationship has been
established between the vaccine and the adverse reaction.\48\
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\46\ Gen. William W. Crouch, U.S. Army Vice Chief of Staff,
memorandum ``Army Anthrax Vaccine Immunization Program Plan,'' Apr. 29,
1998, p. 3 and annex C (in subcommittee files).
\47\ FDA Center for Biologics Evaluation and Research, ``Vaccine
Adverse Events Reporting System [VAERS]'' available at http://
www.fda.gov.cber/vaers/faq.htm.
\48\ Ibid.
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The Army Medical Surveillance Activity also receives copies
of VAERS forms from all the uniformed services and produces a
quarterly report for the U.S. Army Medical Command.\49\ The
Army Surgeon General has requested the assistance of the HHS
Vaccine Injury Compensation Program in evaluating all anthrax-
related VAERS data.\50\
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\49\ See supra note 46, p. C-7.
\50\ Anthrax Vaccine Adverse Reactions, 106th Cong., 1st sess.
(1999) (subcommittee on National Security, Veterans Affairs, and
International Relations hearing of July 21, 1999) [hereinafter ``NSVAIR
anthrax hearing (IV)''] [The subcommittee hearing has not yet been
printed. Page numbers in this and subsequent references to statements
at this hearing refer to individual prepared written statements or the
unofficial transcript, held in subcommittee files.] (prepared statement
of Gen. Robert Claypool, pp. 13-14).
---------------------------------------------------------------------------
The AVIP convened a clinical conference in May 1999 to
discuss anthrax issues, including adverse events. Col. Renata
Engler, M.D., chief, Allergy-Immunology Department, Walter Reed
Army Medical Center, presented data from ongoing research and
case studies showing higher adverse reaction rates in
women.\51\ Also discussed at the conference was the Army
Surgeon General's proposed longitudinal cohort study to assess
near-term and long-term health effects of the anthrax
vaccine.\52\
---------------------------------------------------------------------------
\51\ Col. Renata Engler, M.D., USA, Chief, Allergy and Immunology
Department, Walter Reed Army Medical Center, ``Presentation-Anthrax
Immunization: Challenges for the Future,'' Department of Defense
Conference for Biological Warfare Defense Immunizations, Fort Detrick,
MD, May 25-27, 1999 (in subcommittee files).
\52\ Department of the Army, Office of the Surgeon General,
``Memorandum for Conference Participants,'' Apr. 16, 1999, p. 2 (in
subcommittee files).
---------------------------------------------------------------------------
To convey important information about medical exemptions
and adverse reactions, the Army implementation plan directs
commanders and medical staff to provide recipients ``adequate
information on the vaccine, its safety, its benefits, and the
need for adherence to the immunization schedule prior to the
first anthrax vaccination.'' \53\ The other service
implementation plans contain identical or similar requirements.
---------------------------------------------------------------------------
\53\ See supra note 46 p. C-5.
---------------------------------------------------------------------------
On April 1, 1999, VAERS data (1990 to 1999) contained 101
reports of adverse events associated with anthrax inoculation,
14 of which were considered serious.\54\ In May 1999, DOD
reported a total of 123 VAERS filings with FDA, but included
only 65 of those in the caculation of an adverse reaction rate
of 0.007 percent of 890,888 vaccinations given to date.
According to DOD, only 11 VAERS reports ``met strict reporting
requirements.'' \55\
---------------------------------------------------------------------------
\54\ Testimony of Dr. Kathryn Zoon, Director, FDA Center for
Biologics Evaluation and Research, NSVAIR anthrax hearing (II), p. 55.
\55\ Department of Defense, briefing slide, ``Anthrax Vaccine
Adverse Events-Vaccine Adverse Event Reporting System [VAERS]
Military--Week Ending May 21, 1999'' May 28, 1999 (in subcommittee
files).
---------------------------------------------------------------------------
Independent Medical Review
A review of the AVIP plans, and of basic literature on the
anthrax vaccine, was conducted by Dr. Gerard N. Burrow, of the
Yale University School of Medicine.\56\ According to Dr.
Burrow,\57\ he conducted his review over 3 months, read
materials provided by DOD, and interviewed Pentagon officials
responsible for designing and implementing the program. On
February 19, 1998, in a four page letter, he concluded, ``The
anthrax vaccine appears to be safe and offers the best
available protection against wild-type anthrax as a biological
warfare agent.'' The letter contains two paragraphs on safety
and efficacy. Regarding the safety of the vaccine stockpile,
all of which was manufactured under conditions cited by FDA as
deficient, Dr. Burrow pointed to the DOD supplemental testing
program, and the fact that ``FDA directed MBPI to do a
comprehensive review to demonstrate that deviations in biologic
product lines did not impact anthrax vaccine quality and
integrity. The results of this review should be available in
the near future.'' \58\ Regarding efficacy of the vaccine, the
letter recites usage figures since approval in 1970 and cites
the conclusion of an unpublished DOD study that ``unit
effectiveness could best be preserved through the use of pre-
deployment vaccination.'' \59\
---------------------------------------------------------------------------
\56\ See supra note 16.
\57\ In an Apr. 16, 1999 telephone conversation with subcommittee
staff, Dr. Burrow said his charge was a general review of the program,
and that as an internist, he has little experience with vaccines. His
primary recommendation was the use of focus groups of military
personnel to determine appropriate communication strategies.
\58\ See supra note 16.
\59\ Ibid.
---------------------------------------------------------------------------
In a letter to the subcommittee in response to a request to
testify on his review of the program, Dr. Burrow wrote:
Unfortunately, I do not believe I can make a
significant contribution to the work of your Committee.
I chaired the Institute of Medicine Committee that
reviewed the Defense Department program for clinical
care of Gulf War veterans in active service and
interacted with personnel in the Office of Health
Affairs. The Defense Department was looking for someone
to review the program in general and make suggestions,
and I accepted out of patriotism. I was very clear that
I had no expertise in Anthrax and they were clear that
they were looking for a general oversight of the
vaccination program.
I visited the Pentagon on a number of occasions,
talked with a variety of people in and out of
government and presented my report which you have to
the Secretary on March 2, 1998. I had no access to
classified information. . . .\60\ (Emphasis added).
---------------------------------------------------------------------------
\60\ Letter from Dr. Gerard N. Burrow, Yale University School of
Medicine, to Representative Christopher Shays, Apr. 26, 1999 (in
subcommittee files).
---------------------------------------------------------------------------
Supplemental Testing
To address concerns over the age and quality of stockpiled
vaccine, DOD undertook an effort to re-test the product before
use. A contractor was retained to conduct supplemental testing
of vaccine lots, all of which had been manufactured in an aging
production facility, and some of which had been approved by the
FDA for use beyond the initial expiration date.
Mitretek Systems Inc., reviewed vaccine production records
and observed additional testing conducted by BioPort
personnel.\61\ Of the 31 vaccine lots \62\ subjected by DOD to
supplemental testing, 18 remained unavailable as of July 1999
due to unresolved purity, potency, or sterility issues.\63\
---------------------------------------------------------------------------
\61\ See supra note 17, p. 3.
\62\ Each lot contains approximately 200,000 doses of vaccine.
\63\ See supra note 26, p. 13.
---------------------------------------------------------------------------
Some involved in the program opposed supplemental testing
as redundant and likely to cause more problems than it solved
by establishing a self-imposed vaccine safety standard in
addition to FDA lot-release criteria.\64\ Their concerns were
validated when the supplemental testing program appears to have
overwhelmed the MBPI/BioPort testing capabilities, producing
anomalous results and delaying the program.\65\ Once the
testing problems became apparent, vaccine lots not technically
in the stockpile when the AVIP was announced were not subjected
to the supplemental assays under the rationale the FDA was
requiring the same tests for lot release.\66\ All the lots
submitted for supplemental testing had also undergone the same
FDA lot release protocols.
---------------------------------------------------------------------------
\64\ Dr. Michael Gilbreath, information paper, JPO 0364, Feb. 4,
1998 (in subcommittee files); prepared statement of Dr. Robert C.
Myers, Chief Operating Officer, BioPort Corp., NSVAIR anthrax hearing
(II), pp. 83-84.
\65\ Ibid. (Gilbreath information paper).
\66\ Letter from Secretary of Defense William Cohen to
Representatives Shays (CT), Gilman (NY), Kelly (NY), Souder (IN), Ose
(CA), and Talent (MO), Sept. 30, 1999, attachment p. 1 (in subcommittee
files).
---------------------------------------------------------------------------
Animal Data on Efficacy
DOD's determination the vaccine affords protection against
virtually all strains of airborne anthrax spores rests
primarily on studies of vaccinated animals (guinea pigs,
rabbits, and monkeys) challenged with various strains of the
disease.\67\ But widely varied results within and between
animal species suggest variable modes of protection not
necessarily correlated to antibody levels stimulated by the
vaccine.\68\ Without a proven model in animals that is known to
correlate to protection in humans, animal data remains only
suggestive.
---------------------------------------------------------------------------
\67\ Testimony of Dr. Sue Bailey, DOD Assistant Secretary for
Health Affairs, NSVAIR anthrax hearing (I), p. 11.
\68\ Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing
(II) pp. 108-111.
---------------------------------------------------------------------------
Vaccine-acquired anthrax immunity may also be limited or
overwhelmed when the subject is challenged with variant anthrax
strains.\69\ A report by the Senate Committee on Veterans'
Affairs concluded that:
---------------------------------------------------------------------------
\69\ Ibid.
data suggests that the vaccine can protect humans
against inhaled anthrax but to date there is inadequate
information to judge how well it works, particularly
against weaponized anthrax, which could cause exposure
to greater concentrations of anthrax than has occurred
among workers exposed on the job.\70\
---------------------------------------------------------------------------
\70\ Report of the Special Investigation Unit on Gulf War
Illnesses, Senate Committee on Veterans' Affairs, 105th Cong., 2d
sess., Sept. 1998, S. Rpt. 105-39, p. 122. See aslo, ``Is Military
Research Hazardous to Veteran's Health?-Lessons Spanning Half a
Century,'' staff report prepared for the Committee on Veterans Affairs,
U.S. Senate, p. 11, 103rd Cong., 2d sess., S. Rpt. 103-97, Dec. 8,
1994.
In response to questions regarding the efficacy of the
vaccine against antibiotic resistant or genetically altered
---------------------------------------------------------------------------
anthrax strains, DOD said
The current US-licensed anthrax vaccine is considered
to be highly effective against naturally occurring
strains of anthrax, including antibiotic resistant
strains. The development of genetically engineered
organisms using anthrax or any other biological warfare
agent is a potential threat that must be evaluated
carefully. We are not aware, however, of any
information to suggest that these modified strains have
been used in any context other than the research
laboratory.\71\
---------------------------------------------------------------------------
\71\ See supra note 66.
When one U.S. laboratory studying the release of anthrax at
Sverdlovsk implied the Russian mixtures of anthrax strains
might overcome the protection afforded by the anthrax vaccine,
DOD persuaded the author ``to correct the press release to make
it more accurate.'' The modification stated, in part, ``there
is no experimental data or evidence to suggest that such a
mixture is resistant to the FDA-licensed anthrax vaccine used
by the US military.'' \72\
---------------------------------------------------------------------------
\72\ Ibid. Nor is there data demonstrating the vaccine is effective
against altered or mixed anthrax strains.
---------------------------------------------------------------------------
Opposition to the AVIP
Some have refused the vaccine. Active duty personnel have
been disciplined under service-specific policies for refusing a
lawful order. Reservists and National Guard members have
resigned or transferred to units or ``non-mobility'' positions
which do not require the vaccine. The DOD does not collect
uniform records on refusals, but media reports indicate more
than 300 service men and women have refused to take the
shot.\73\
---------------------------------------------------------------------------
\73\ ``Vaccine Refused by 23 Aircraft Carrier Sailors,'' Associated
Press, Mar. 11, 1999 (in subcommittee files). The reported number of
vaccine refusers has remained fairly stable in public reports, between
200 and 300, for some months.
---------------------------------------------------------------------------
Hearing testimony and correspondence from Reservists and
National Guard members suggests up to 30 percent of some units
would resign or seek to transfer due to the anthrax
program.\74\ Their concerns focus on the lack of systematic,
long-term studies on anthrax vaccine health effects.\75\
---------------------------------------------------------------------------
\74\ Impact of the Anthrax Vaccine Program on Reserve and National
Guard Units, 106th Cong., 1st sess., p. 57 (Subcommittee on National
Security, Veterans Affairs and International Relations hearing, Sept.
29, 1999) [hereinafter ``NSVAIR anthrax hearing (V)''] [The
subcommittee hearing has not yet been printed. Page numbers in this and
subsequent references to statements at this hearing refer to individual
prepared written statements or the unofficial transcript, held in
subcommittee files.] Testimony of Capt. David Panzera; testimony of
Tech. Sgt. William Mangieri, NSVAIR anthrax hearing (V), p. 58) see
also, testimony of Capt. Thomas Rempfer, NSVAIR anthrax hearing (I), p.
110; testimony of Maj. Redmond Handy, NSVAIR anthrax hearing (I), pp.
102-102. DOD does not collect data on refusals or resignations
attributable to the vaccine. An informal survey of Reserve and Guard
units shows more than 700 current or likely departures due to the AVIP.
The survey can be found at: http://www.dallasnw.quik.com/cyberella/
Anthrax/Chron--Info.html, pp. 12-13.
\75\ Testimony of Col. Redmond Handy, NSVAIR anthrax hearing (I),
p. 91; prepared statement of Ms. Randi Martin-Allaire, NSVAIR anthrax
hearing (II), p. 171; prepared statement of Sgt. Michael Shepard,
NSVAIR anthrax hearing (II), p. 193; testimony of Major Cheryl Hansen,
NSVAIR anthrax hearing (V), p. 31.
---------------------------------------------------------------------------
Safety is also an issue for some because the anthrax
vaccine is one of the exposures under study by the National
Academy of Sciences' Institute of Medicine [IOM] pursuant to
the Persian Gulf War Veterans Act of 1998, enacted as Title XVI
of the 1998 Omnibus Appropriations Act, Public Law 105-277. The
law directs IOM to review associations between illnesses and
wartime exposures that warrant a presumption of service-
connection for sick Gulf war veterans.\76\ That study is
ongoing.
---------------------------------------------------------------------------
\76\ Public Law 105-277, title XVI.
---------------------------------------------------------------------------
Efforts to meet Secretary Cohen's four preconditions to
AVIP implementation, intended to address likely reservations
about the program, have only served to intensify concerns: \77\
---------------------------------------------------------------------------
\77\ Letter from Representativess Benjamin Gilman (NY), et. al. to
Defense Secretary William Cohen, July 20, 1999, p. 1 (in subcommittee
files).
---------------------------------------------------------------------------
1. Problems with supplemental testing underscore
vaccine safety and production issues. The failure to
test all lots produced before the plant closed suggests
to some the promise of supplemental testing was not
fulfilled.
2. The prerequisite communication effort engenders
resentment and mistrust as simplistic DOD attempts at
education and risk communication portray very limited
vaccine use as ``routine'' \78\ and attack those with
legitimate questions as ``paranoics'' \79\ and simple-
minded victims of Internet propaganda.\80\
---------------------------------------------------------------------------
\78\ See supra note 14.
\79\ Lt. Gen. Ronald Blanck, ``Ignore the Paranoics: The Vaccine is
Safe,'' Army Times, Feb. 2, 1999, p. 12.
\80\ Douglas J. Gilbert, American Forces Press Service, ``Anthrax
Vaccine Called Effective Force Protection,'' DefenseLink, Nov. 5, 1998
(in subcommittee files); Washington Times, ``Anthrax Shots Drive Air
Force Veteran From Service,'' Oct. 13, 1999, p. 18; PBS New Hour,
``Anthrax Vaccine,'' Oct. 21, 1999 (comments of Gen. Blanck)
(transcript in subcommittee files); Col. Guy Strawder, ``AVIP
Director's Newsletter'' (in subcommittee files).
---------------------------------------------------------------------------
3. Delays in posting data to the tracking system
reduce its value as a real time indicator of medical
readiness and increases tolerance of deviations in the
FDA approved inoculation regimen.\81\
---------------------------------------------------------------------------
\81\ Bradley Graham, ``Anthrax Shots Missing Targets?'' Washington
Post, Sept. 29, 1999, p. A27.
---------------------------------------------------------------------------
4. Contrary to subsequent DOD characterizations, the
promised outside, expert, scientific review of the
program was only very general in nature.\82\
---------------------------------------------------------------------------
\82\ See supra note 60 and accompanying text.
---------------------------------------------------------------------------
Others question the necessity of the program, asking
whether it betrays a lack of confidence in deterrence and other
force protection elements, and suggesting a vaccine program
makes anthrax attack more, not less, likely.\83\
---------------------------------------------------------------------------
\83\ Testimony of Capt. Thomas Rempfer, NSVAIR anthrax hearing (I),
pp. 40-41; testimony of Maj. Russell Dingle, NSVAIR anthrax hearing
(I), p. 49.
---------------------------------------------------------------------------
Hearings and Legislative Proposals
On March 24, 1999, the Subcommittee on National Security,
Veterans Affairs, and International Relations held the first of
five hearings on the Department of Defense [DOD] Anthrax
Vaccination Immunization Program [AVIP] entitled, ``The Anthrax
Immunization Program,'' the hearing examined the effectiveness
and efficiency of the AVIP as a medical force protection
measure, a recordkeeping initiative and long term procurement.
The subcommittee heard testimony from Dr. Sue Bailey, Assistant
Secretary for Health Affairs, U.S. Department of Defense,
accompanied by, Lt. Gen. Ronald R. Blanck, U.S. Army; Rear
Admiral Todd Fisher, Deputy Surgeon General U.S. Navy; Lt. Gen.
Charles H. Roadman II, U.S. Air Force; Capt. Thomas Rempfer,
Connecticut Air National Guard; Maj. Russell Dingle,
Connecticut Air National Guard; Pfc. Stephen M. Lundbom, U.S.
Marine Corps; Attorney Mark Zaid; Col. Redmond Handy, Member
Reserve Officer Association; and Lorene K. Greenleaf.
On April 29, 1999, the subcommittee held a hearing on the
AVIP entitled, ``DOD's Mandatory Anthrax Vaccine Immunization
Program for Military Personnel.'' The purpose of this hearing
was to examine the vaccine's safety and effectiveness against
an aerosolized biological weapons attack. Individuals who
testified disputed the Department of Defense claim the vaccine
is unquestionably safe for force wide use. Some who testified
are experiencing serious illnesses they associate with the
anthrax vaccine. Testimony was received from Kwai-Cheung Chan,
Director, Special Studies and Evaluations Section, National
Security and International Affairs Division, General Accounting
Office; Dr. Katherine Zoon, Director, Center for Biologics
Evaluation and Research, Food and Drug Administration; Dr.
Michael Gilbreath, Medical Project Manager, Joint Program
Office for Biological Defense; Dr. Robert Myers, Chief
Operating Officer, BioPort Corp.; Dr. Meryl Nass; David
Churchill; Randi Martin-Allaire; Roberta Groll; and Michael
Shepard.
On June 30, 1999 the subcommittee held a hearing entitled,
``Department of Defense's Sole Source Anthrax Vaccine
Procurement.'' The primary focus was to examine AVIP
acquisition strategies and procurement activities pursued by
the Department of Defense to purchase the vaccine. Issues
examined included the technical and financial ability of
BioPort to supply the vaccine at the contracted price, and the
effect of management problems on the safety and the quality of
the vaccine produced. Testimony was given by Louis J.
Rodrigues, Director, Defense Acquisition Issues, National
Security and International Affairs Division, General Accounting
Office; David Oliver, Jr., Principal Deputy Under Secretary of
Defense for Acquisition and Technology, Department of Defense;
and Fuad El-Hibri, chief executive officer, BioPort Corp.
On July 21, 1999, the National Security Subcommittee held
its fourth hearing on the AVIP. Entitled, ``Anthrax Vaccine
Adverse Reactions,'' the hearing focused on the program's
willingness to recognize and ability to treat adverse reactions
to the vaccine in military personnel. Issues discussed included
the extent the main adverse event surveillance system used by
DOD, the joint FDA/CDC Vaccine Adverse Event Reporting System
[VAERS], under-reports adverse events and adverse vaccine
reactions. Testifying at this hearing were CPT Michelle Piel,
USAF; LT Richard Rovet, USAF; SGT Robert Soska, USA; CPT Jon
Richter, USAR; Kwai-Cheung Chan, Director, Special Studies and
Evaluations Section, National Security and International
Affairs Division, General Accounting Office; MG Robert
Claypool, Deputy Assistant Secretary for Health Operations
Policy, Department of Defense accompanied by, RADM Michael
Cowen, Deputy Director for Medical Readiness, Joint Staff,
Department of Defense; COL Renata Engler, Chief, Allergy-
Immunology Department, Walter Reed Army Medical Center; and Dr.
Susan Ellenberg, Director, Division of Biostatistics and
Epidemiology, Center for Biologics Evaluation and Research,
Food and Drug Administration.
The subcommittee held its fifth hearing on the AVIP on
September 29, 1999 entitled, ``Impact of the Anthrax Vaccine
Program on Reserve and National Guard Units.'' The hearing
examined the implementation of the AVIP in reserve component
units and the impact of the program on retention, readiness,
and morale. Testifying at the hearing were Lt. Col. Thomas
Heemstra, Indiana Air National Guard; Maj. Cheryl Hansen, Air
Force Reserves; Capt. David Panzera, New York Air National
Guard; Tech. Sgt. William Mangiere, New York Air National
Guard; Charles Cragin, Acting Assistant Secretary for Reserve
Affairs, Department of Defense, accompanied by, Maj. Gen. Paul
Weaver, Jr., Director, Air National Guard, Department of
Defense; Col. Frederick Gerber, Director, Health Care
Operations, Office of the Army Surgeon General, Department of
Defense; and Col. James Dougherty, Air Surgeon, National Guard
Bureau, Department of Defense.
In the first session of the 106 Congress, two bills were
introduced regarding the anthrax vaccine program:
Representative Walter Jones (NC) introduced H.R. 2543
on July 16, 1999. Entitled, ``The American Military
Health Protection Act,'' the bill would instruct the
Department of Defense to make the anthrax vaccination
immunization program voluntary for all members of the
Armed Forces until the FDA has approved a new anthrax
vaccine for humans or the FDA has approved a new,
reduced course of shots for the current anthrax
vaccine. This bill was referred to the Committee on
Armed Services.
Representative Benjamin Gilman (NY), introduced H.R.
2548 on July 19, 1999, cosponsored by Representatives
Sue Kelly (NY) and Bob Filner (CA). H.R. 2548 would
suspend further implementation of the Department of
Defense anthrax vaccination program until the vaccine
is determined to be safe and effective through a study
by the National Institutes of Health. The Department of
Defense Anthrax Vaccination Moratorium Act was referred
to the Committee on Armed Services and to the Committee
on Commerce.
The fiscal year 2000 Defense Appropriations Act (H.R.
2561) contained a provision directing the Comptroller
General to report on: effects on morale, retention and
recruiting; the civilian costs and burdens associated
with adverse reactions for members of the reserve
components; adequacy of long and short term health
monitoring; assessment of the anthrax threat, including
but not limited to foreign doctrine, weaponization,
quality of intelligence, and other biological threats.
DOD was directed to contract with the National Research
Council to conduct studies on: vaccine adverse events
and adverse reactions, particularly among women;
vaccine efficacy against inhalation anthrax;
correlation of animal models to safety and efficacy in
humans; research gaps; and other matters.
III. Discussion
Findings
1. The AVIP is well-intentioned but over-broad response to the anthrax
threat. It represents a doctrinal departure overemphasizing the
role of pre-exposure medical intervention in force protection
DOD bases the scope of AVIP on the scope of the threat, and
the perceived need for additional, individual force protection
to meet that threat. Threat assessment requires objective and
subjective analyses of U.S. vulnerability, enemy capacity, and
enemy intentions. ``A threat analysis, the first step in
determining risk, identifies and evaluates each threat on the
basis of various factors, such as its capability and intent to
attack an asset, the likelihood of a successful attack, and its
lethality.'' \84\
---------------------------------------------------------------------------
\84\ Combating Terrorism--Threat and Risk Assessments Can Help
Prioritize and Target Program Investments, U.S. General Accounting
Office, GAO/NSIAD-98-74, April 1998 p. 3.
---------------------------------------------------------------------------
Since the King of Athens poisoned his enemy's wells in 600
BC and Alexander the Great hurled diseased animal corpses over
the walls of a besieged city, ground forces have been
vulnerable to casualties caused by natural or pernicious
exposure to chemical and biological pathogens.\85\ But in the
absence of proven capability and intent to use biological
weapons, vulnerability alone does not constitute a validated
threat for purposes of determining appropriate and effective
countermeasures.
---------------------------------------------------------------------------
\85\ Dr. Stephen C. Joseph, Assistant Secretary of Defense for
Health Affairs, ``Biological Warfare--Information Memorandum''
(undated) p. 2 (in subcommittee files).
---------------------------------------------------------------------------
Appropriately, much of the information regarding the BW
capabilities and intentions of potential adversaries, and even
allies, is classified. As a result, most public descriptions of
the anthrax threat focus on the general vulnerability of
unprotected forces to anthrax attack, the general ease and
availability of anthrax production and the likely lethality of
a successful anthrax attack.
According to various unclassified DOD statements, more than
10 countries ``have, or are developing, a biological warfare
capability.'' \86\ Those nations are: China, Iran, Iraq,
Israel, Libya, North Korea, South Korea, Syria, Taiwan, and
Russia. Other public lists also include Egypt, Cuba, Japan, and
the former Soviet states in Eastern Europe that may have
inherited bio-warfare capabilities.\87\ For purposes of the
AVIP, ``The high threat areas validated by our intelligence
community for the potential use of anthrax as a biological
weapon of mass destruction includes [sic] Korea, Israel,
Jordan, Kuwait, Saudi Arabia, Bahrain, Qatar, Oman, UAE, and
Yemen.'' \88\ Anthrax is not seen as a threat in the
Balkans.\89\
---------------------------------------------------------------------------
\86\ DOD information paper,``DOD Biological Warfare Threat
Analysis,'' Dec. 15, 1997, p. 1. See also, Proliferation: Threat and
Response, Department of Defense, November 1997.
\87\ Office of Technology Assessment, U.S. Congress,
``Proliferation of Weapons of Mass Destruction: Assessing the Risks,''
p. 65, OTA-15C-559, August 1993 (in subcommittee files). Notably
included among those nations are United States allies who, it must be
presumed, pose less danger to U.S. forces than nations currently
opposing U.S. policy goals.
\88\ See supra note 66, attachment p. 13.
\89\ Ibid.
---------------------------------------------------------------------------
Other descriptions of the anthrax threat focus on the
relative ease of acquisition, mass production, and
weaponization of the stable, long-lasting anthrax microbe.
According to DOD, production of biological warfare agents does
not require specialized equipment or advanced technology.
Biological agents are more potent and efficient than chemical
weapons, and can be delivered through a variety of means.
Legitimate uses (i.e., vaccine manufacture) for ``dual use''
production technologies make counter-proliferation strategies
difficult to implement successfully.\90\
---------------------------------------------------------------------------
\90\ See supra note 86. The release of deadly chemical sarin gas in
Tokyo by the Aum Shinrikyo cult highlighted the terrorist, and by
implication, the military threat posed by chemical and biological
weapons. But subsequently acquired information regarding the cult's
unsuccessful attempts to use biological agents is seen by some as a
counter to the argument those agents are not technically challenging to
produce and deploy.
---------------------------------------------------------------------------
Secretary Cohen told Members, ``Anthrax poses a clear and
present danger to our armed forces. It is the weapon of choice
for germ warfare because it is easy to weaponize and is as
lethal as the Ebola virus. At least seven potential adversaries
have worked to develop the offensive use of anthrax.'' \91\
---------------------------------------------------------------------------
\91\ See supra note 66.
---------------------------------------------------------------------------
In testimony before a subcommittee of the House Armed
Services Committee, Deputy Secretary of Defense John Hamre
said, ``Currently, at least 10 nation states and 2 terrorist
groups are known to possess, or have in development, a
biological warfare capability.'' \92\
---------------------------------------------------------------------------
\92\ Prepared statement of John J. Hamre, Deputy Secretary of
Defense, submitted to the Subcommittee on Military Personnel, House
Committee on Armed Services, p. 2, Sept. 30, 1999.
---------------------------------------------------------------------------
DOD testimony to the subcommittee portrayed the threat
similarly: ``As identified by the chairman of the Joint Chiefs
of Staff, anthrax is a major threat to our troops. Anthrax is
the primary biological warfare threat faced by U.S. forces.
More than 10 countries, including Iraq, have or are suspected
of developing this biological warfare capability. Anthrax is
the biological weapon most likely to be encountered because it
is highly lethal, easy to produce in large quantities, and
relatively easy to develop as a weapon.'' \93\
---------------------------------------------------------------------------
\93\ Prepared statement of Dr. Sue Bailey, DOD Assistant Secretary
for Health Affairs, NSVAIR anthrax hearing (I), p. 8.
---------------------------------------------------------------------------
The AVIP tri-fold brochure describes the threat as follows:
Biological weapons are maintained by several countries
around the world. Use of these weapons could cause
widespread illness among unprotected military forces.
Anthrax is the biological weapon most likely to be
encountered because it is:
Highly lethal
Easy to produce in large quantities
Relatively easy to develop as a weapon
Easily spread over a large area
Easily stored and dangerous for a long time
\94\
---------------------------------------------------------------------------
\94\ See supra note 14.
Clearly, DOD has determined the threat is real and
imminent, and has concluded it would be irresponsible not to
deploy an available countermeasure to protect the lives and
fighting capability of U.S. forces.\95\
---------------------------------------------------------------------------
\95\ Prepared statement of Dr. Sue Bailey, DOD Assistant Secretary
for Health Affairs, NSVAIR anthrax hearing (I), p. 13.
---------------------------------------------------------------------------
But similar statements on the threat have been made by DOD
for many years. According to GAO testimony, ``The nature and
magnitude of the military threat of biological warfare [BW] has
not changed since 1990, both in terms of the number of
countries suspected of developing BW capability, the types of
BW agents they possess, and their ability to weaponize and
deliver those BW agents. Inhalation anthrax is considered by
DOD to be the primary BW threat because of its lethality, ease
of production, and weaponization.'' \96\
---------------------------------------------------------------------------
\96\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Affairs Division, U.S. General Accounting Office, NSVAIR anthrax
hearing (II), p. 12.
---------------------------------------------------------------------------
According to unclassified briefing materials assessing the
anthrax threat, anthrax stocks and weaponized anthrax have been
confirmed only in Southwest Asia. A stock of anthrax has been
confirmed in Northeast Asia. Capacity to produce and weaponize
anthrax elsewhere (South Asia or transnational) is suspected
but unconfirmed.\97\
---------------------------------------------------------------------------
\97\ DOD, briefing slide entitled, ``Anthrax Threat,'' Apr. 20,
1998 (in subcommittee files).
---------------------------------------------------------------------------
Assessment of the Iraqi threat concludes that substantial
anthrax production capacity exists but exceeds the ability to
weaponize. While Iraq appears likely to be able to launch a BW
attack using AL HUSSEIN ballistic missiles, aircraft delivery
is seen as less likely due to United States and Coalition air
superiority.\98\ So Saddam would be ``unlikely to use WMD
unless he perceives regime's survival at stake.'' \99\
---------------------------------------------------------------------------
\98\ DOD, briefing slide entitled, ``Assessment,'' Apr. 20, 1998
(in subcommittee files).
\99\ Ibid.
---------------------------------------------------------------------------
So the threat remains tactically limited and regional. The
AVIP is universal.
Several factors appear to have fueled the 1997 decision to
launch a mandatory, force-wide program to address a long
acknowledged, regionally-based threat.
After the Gulf war, the Department of Defense undertook
what is now characterized as ``a detailed, deliberative
process'' \100\ over more than 3 years that culminated in the
conditional decision to implement a mandatory, force-wide
anthrax immunization program. ``After a three year study, the
Department has concluded that the vaccination is the only safe
way to protect highly mobile U.S. military forces against a
potential threat that is 99 percent lethal to unprotected
individuals.'' \101\
---------------------------------------------------------------------------
\100\ Prepared statement of Dr. Sue Bailey, Assistant Secretary of
Defense for Health Affairs, NSVAIR anthrax hearing (I), p. 8.
\101\ Letter from Sandra K. Stuart, Assistant Secretary of Defense
(Legislative Affairs) to the Honorable Christopher Shays (CT), p. 1,
Dec. 15, 1997.
---------------------------------------------------------------------------
That study was conducted, for the most part, behind closed
doors. However, the documentation provided to the subcommittee
by DOD \102\ describes a process more predetermined than
deliberative, as the obvious operational benefits of passive,
pre-exposure protection (versus cumbersome protective masks and
suits), and the Iraqi threat, drove the decision to use the
only vaccine currently available.\103\
---------------------------------------------------------------------------
\102\ Letter from Representative Christopher Shays, chairman,
Subcommittee on National Security, Veterans Affairs, and International
Relations, House Committee on Government Reform to Secretary of Defense
William Cohen, May 12, 1999 (in subcommittee files).
\103\ Department of Defense, information paper, ``DOD Biological
Warfare Force Protection,'' Dec. 15, 1997, p. 2 (in subcommittee
files).
---------------------------------------------------------------------------
In November 1993, DOD Directive 6205.3 set out a broad
policy supporting immunization research, development, testing,
acquisition and stockpiling of vaccines against current and
emerging biological warfare threats. The directive required
immunization only of ``designated'' or ``programmed'' personnel
against agents ``for which suitable vaccines are available, in
sufficient time to develop immunity before deployment to high
threat areas. . . .'' \104\
---------------------------------------------------------------------------
\104\ See supra note 7, p. 2.
---------------------------------------------------------------------------
With regard to anthrax, DOD conducted research and program
planning to develop an ``improved anthrax vaccine'' [IAV] that
would generate immunity against the known threat in a
reasonable time. According to a DOD Operational Requirements
Document [ORD], the need for an improved vaccine was identified
in the Mission Needs Statement [MNS] for medical defense
against chemical and biological warfare agents in August 1994
and in the MNS for Department of Defense biological defense in
August 1992.\105\
---------------------------------------------------------------------------
\105\ Department of Defense, ``Operational Requirements Document
[ORD] for Improved Anthrax Vaccine,'' Oct. 2, 1995, p. 1 (in
subcommittee files).
---------------------------------------------------------------------------
The mission profile for the improved vaccine called only
for inoculation of deployed and rapid deployment units ``based
on intelligence estimates of the potential for use of specific
BW agents against U.S. forces. . . . Other military personnel
will be vaccinated prior to departure to BW threat areas. An
accelerated immunization program will be conducted under
certain alert or mobilization conditions.'' \106\
---------------------------------------------------------------------------
\106\ Ibid., p. B-1.
---------------------------------------------------------------------------
Shortcomings of the currently licensed vaccine were seen as
the ``serious logistical obstacles, especially for reserve
forces'' posed by the approved six-shot schedule and reports
that suggest ``this vaccine may not provide universal
protection against all anthrax strains.'' \107\ Minimum
standards for the improved vaccine included generation of a
protective immune response within 14 days of administering
three inoculations.
---------------------------------------------------------------------------
\107\ Ibid., p. 2.
---------------------------------------------------------------------------
Briefing materials produced by the U.S. Army Medical
Research Institute of Infectious Disease [USAMRIID] in 1994
listed the following problems with the current vaccine:
Prolonged immunization schedule
Reactogenicity:
Systemic reactions: 0.7-1.3%
Significant local reactions: 2.4-3.9% (5.9%)
Vaccine components completely undefined in terms of
characterization and quantitation of the PA, and other
bacterial products and constituents present
Significant lot-to-lot variation in the PA immunogen
content
Human trials with similar but not identical vaccine
showed protection against cutaneous anthrax but
insufficient data to show efficacy against inhalation
anthrax
Made from spore-forming strain requiring dedicated
production facility \108\
---------------------------------------------------------------------------
\108\ U.S. Army Medical Research Institute of Infectious Diseases
[USAMRIID], briefing slide, ``Problems with Current MDPH Vaccine,''
(undated) (in subcommittee files).
---------------------------------------------------------------------------
Minutes of a May 1994 USAMRIID meeting addressed ``the
Army's need for a new Anthrax vaccine. This need is based on
reactogenicity of the current vaccine, the desire to make a
vaccine with defined and well characterized components, and the
need to produce a vaccine which does not require a BL-3 \109\
containment for production or a dedicated production facility,
since B. anthracis is a spore former.'' \110\
---------------------------------------------------------------------------
\109\ Bio-Safety Level 3, the second most stringent of the four
levels of controls to protect persons handling infectious agents. For a
description of current bio-safety standards see: http://www.cdc.gov/od/
ohs/biosfty/bmbl4/bmbl4s3t.htm.
\110\ See supra note 44, p. 1.
---------------------------------------------------------------------------
Iraq's 1995 declarations to the United Nations Special
Commission [UNSCOM] described ``a substantial BW program''
\111\ including 8,000 liters of anthrax, 6,000 of which Iraq
claimed to have weaponized in missile warheads, aerial bombs,
rockets, remote-control aircraft and agricultural sprayers
mounted on planes and helicopters.\112\ At the same time, DOD
interest in an improved anthrax vaccine diminished sharply.
Reservations about the suitability of the old vaccine were put
aside once it was made the centerpiece of the proposed
immunization effort.
---------------------------------------------------------------------------
\111\ See supra note 85, p. 5.
\112\ Ibid.
---------------------------------------------------------------------------
The vaccine program is just one element of the Joint
Biological Warfare Defense concept encompassing:
detection and warning
individual (masks, suits) and collective
protection (sealed command and control facilities)
medical (vaccines) countermeasures to prevent
disease
contamination avoidance
decontamination \113\
---------------------------------------------------------------------------
\113\ Ibid., p. 7.
---------------------------------------------------------------------------
Treaties, anti-proliferation regimes, as well as the prospect
of tactical and nuclear retaliation, are also meant to deter
use of chemical and biological weapons.
These are meant to be parts of an ``integrated and
overlapping systems approach to BW defense ''\114\ in which
both military and medical considerations dictate a hierarchy of
force protection measures emphasizing contamination avoidance
and physical protection over medical intervention and
decontamination. One statement of chem/bio defense doctrine
ranks force protection strategies as follows:
---------------------------------------------------------------------------
\114\ DOD, Medical Defense Against Biological Material, (undated)
p. 1.
. . . The most effective and singularly most important
prophylaxis in defense against biological warfare
agents is physical protection. Preventing exposure of
the respiratory tract and mucous membranes . . . to
infectious and/or toxic aerosols through use of a full-
face respirator will prevent exposure, and should,
theoretically, obviate the need for additional
measures. Chemical protective masks effectively filter
biological hazards.
. . . All medical prophylactic modalities described
should be viewed only as secondary (i.e., backup), and
are not be relied upon as primary protective measures.
Agent exposures near the source of dissemination will
be high, and likely to overwhelm any medical protective
measure.\115\
---------------------------------------------------------------------------
\115\ Ibid. The section on Prophylaxis and Therapy continues: ``The
precise efficacy of available medical countermeasures has, of course,
never been evaluated in actual field circumstances, but is largely
inferred from laboratory studies on nonhuman primates. While these
extrapolations may be inexact, they strongly support the efficacy of
vaccines and drugs at some agent dose.'' (Emphasis in original).
The AVIP makes medical prophylaxis a primary aspect of
force protection and CBW deterrence. In testimony, the DOD
Assistant Secretary for Health Affairs put the proposition
quite directly: ``Our greatest and prime biological enemy today
is anthrax. And our strongest weapon against anthrax is
vaccination.'' \116\ The Navy's Deputy Surgeon General added:
---------------------------------------------------------------------------
\116\ Testimony of Lt. Gen. Charles H. Roadman, Surgeon General,
USAF, NSVAIR anthrax hearing (I), p. 17.
We are fortunate to have a time tested, safe and
effective vaccine to provide an important element of
the body armor needed to defend our personnel against
weaponized anthrax. Anthrax has now joined other
immunizations received by our Service men and women to
protect against disease threats just as important as
wearing a gas mask or carrying a rifle when on the
battlefield.\117\
---------------------------------------------------------------------------
\117\ Testimony of R.Adm. Todd Fisher, Deputy Surgeon General, USN,
NSVAIR anthrax hearing (I), p. 17.
The Air Force Surgeon General expressed a similar
rationale: ``In addition to the potential human cost, mass
casualties would degrade our military mission, military
capability and mission accomplishment. We would not send people
into battle without helmets and weapons. So we should also
provide the best armor against biological dangers that we can.
That armor is immunization.'' \118\
---------------------------------------------------------------------------
\118\ Testimony of Lt. Gen. Charles H. Roadman, II, Surgeon
General, USAF, NSVAIR anthrax hearing (I), p. 18.
---------------------------------------------------------------------------
But some service members see an important difference
between the physical body armor worn in battle, which can be
removed, and medical prophylaxis, which cannot. ``The body
armor that our Department of Defense refers to is perceived by
many service members as `tin foil armor.' '' \119\
---------------------------------------------------------------------------
\119\ Testimony of Captain Thomas Rempfer, NSVAIR anthrax hearing
(I), p. 40.
---------------------------------------------------------------------------
Primary reliance on medical intervention may also undermine
confidence in other elements of the force protection hierarchy.
One hearing witness asked if the vaccine might not ``create a
facade of force protection'' provoking an adversary to even
more lethal chem/bio or conventional attack.\120\ He noted:
---------------------------------------------------------------------------
\120\ Ibid.
These foundations of force protection rely on a
credible willingness to use force. This resolve won the
Cold War and it won the Gulf war. Abandoning this time
tested doctrine and emphasizing the inevitability of
biological attack to advocate a defensive anthrax
vaccination policy may inadvertently result in
legitimizing biological warfare.\121\
---------------------------------------------------------------------------
\121\ Ibid.
The vaccine policy also reflects a lack of confidence in
current force protection equipment. Physical barriers,
effective against all toxins and microbes if used properly and
in time, are now viewed as ``likely to remain only partially
effective for the foreseeable future.'' \122\ Protective suits
and masks ``degrade individual operating capabilities and force
effectiveness . . .'' \123\ The purpose of the current doctrine
on bio/chemical defense ``is to maintain combat operations
unencumbered by contamination and the wearing of the protective
gear.'' \124\
---------------------------------------------------------------------------
\122\ See supra note 85, p. 11.
\123\ Ibid.
\124\ See supra note 103.
---------------------------------------------------------------------------
Even this doctrinal reliance on the primacy of medical
protection does not necessarily demand the universal, pre-
deployment inoculation that characterizes the AVIP. Throughout
the policy deliberation process, the option was considered to
hold vaccines in stockpiles and defer actual immunization until
mobilization to a threat area.\125\ As late as September 1997,
decision memoranda to the Under Secretary of Defense contained
a recommendation to: ``Maintain the planning guidance for total
force immunization as a contingency plan, ready for finalizing,
coordination, and approval at the appropriate time based on:
(a) resolution, in conjunction with the FDA, of facility
production issues; and/or (b) changes in the validated anthrax
biological warfare threat.'' \126\
---------------------------------------------------------------------------
\125\ Dr. Edward D. Martin, et. al., Acting Assistant Secretary of
Defense (Health Affairs), Department of Defense, ``Memorandum for
Deputy Secretary of Defense--Anthrax Vaccination Implementation Plan--
ACTION MEMORANDUM,'' p. 1, Sept. 19, 1997 (in subcommittee files).
\126\ Ibid., p. 2.
---------------------------------------------------------------------------
The decision to launch the force-wide, mandatory
immunization program, despite well documented misgivings about
the vaccine and the capacity of the vaccine manufacturer, seems
to have been driven by a genuine concern to avoid casualties, a
military requirement for theoretically uniform protection
within deployed units, an expansive view of demands on U.S.
troop mobility, and the daunting logistics of the chosen
vaccine.
``Why is it essential that the anthrax immunization be
mandatory? Military commanders have the responsibility to
ensure the health and safety of their troops and to carry out
their mission responsibilities. Anthrax is a serious threat. We
have a safe and efficacious vaccine. To not use the vaccine
constitutes a failure to protect our troops and a risk to
carrying out military missions.'' \127\ According to DOD, ``We
are morally obligated to provide the best protection we are
capable of providing to our troops--in the case of protection
against anthrax, there is a vaccine to provide individual
immunity to this biological warfare agent.'' \128\ According to
Dr Bailey, ``Like other vaccines that are required to prepare
military personnel for deployment, the anthrax vaccine is
mandatory.'' \129\
---------------------------------------------------------------------------
\127\ Prepared statement of Dr. Sue Bailey, Assistant Secretary of
Defense for Health Affairs, NSVAIR anthrax hearing (I), p. 10.
\128\ DOD, Public Affairs Talking Points, p. 1, Dec. 15, 1997.
\129\ Prepared statement of Dr. Sue Bailey, Assistant Secretary of
Defense for Health Affairs, NSVAIR anthrax hearing (I), p. 10.
---------------------------------------------------------------------------
But the anthrax vaccine requirement differs from general
military immunization and chemoprophylaxis policy in two
significant respects. Other inoculations are required pursuant
to medical, not military command authority,\130\ and they are
required primarily to maintain and protect the health of
personnel from naturally occurring diseases or pathogens
endemic to specific duty or deployment areas. Although the
threat of natural anthrax ``remains a significant problem in
numerous countries throughout Africa, the Middle East, Europe
and Asia,'' \131\ the general military immunization policy
contains no reference to the anthrax vaccine.
---------------------------------------------------------------------------
\130\ Department of Defense, Medical Services--Immunizations and
Chemoprophylaxis, Army Regulation 40-562, NAVMEDCOMINST 6230.3, AFR
161-13, CG COMDTINST M6230.4D, Oct. 7, 1988.
\131\ See supra note 105, p. 1.
---------------------------------------------------------------------------
When asked how the United States program compared to the
approach of allied forces, such as Great Britain which began a
voluntary program, or Israel which appears to rely primarily on
antibiotic treatments, the Pentagon responded, ``DOD does not
base its policies on those of our allies or coalition
partners.'' \132\ Because ``our Armed Forces must be prepared
to conduct successful military operations worldwide at a
moments [sic] notice,'' DOD believes the ``mandatory AVIP is
clearly in our best interests and strongly supports our
national security and military strategies.'' \133\
---------------------------------------------------------------------------
\132\ See supra note 66, p. 14.
\133\ Ibid.
---------------------------------------------------------------------------
But there will be exceptions. A July 1999 Defense Threat
Reduction Agency policy on anthrax immunization says:
Deploying civilian employees who decline to participate
in the DTRA-AVIP will be required to execute a
``Statement of Informed Declination'' attesting to the
Agency's offer of anthrax immunization and the
individual's decision to decline. By signing this
statement, the employee acknowledges and willingly
assumes the enhanced medical risk associated with
travel to affected regions without receiving the
recommended vaccinations. Hence, his/her deployment to
these regions in support or mission requirements will
not necessarily be precluded. This statement will
become a part of the individual's permanent
Occupational Health Record.\134\
---------------------------------------------------------------------------
\134\ Defense Threat Reduction Agency, Policy Memorandum 99-22,
July 23, 1999, p. 2 (in subcommittee files).
One of the primary reasons for the mandatory AVIP is the
perceived need for consistent levels of force protection within
and between deployed units to guarantee military effectiveness.
Field commanders need to know the capabilities of their
members. But even the force-wide, mandatory anthrax vaccine
program is unlikely to meet that need. DOD concluded, but
cannot prove, that individual antibody response to the vaccine
equals protection from anthrax attack. That is, DOD believes
the more anthrax-fighting antibodies produced, the more medical
``body armor'' has been acquired. Animal studies suggest this
may be the case for some species, but no correlate has been
developed to permit extrapolation of this conclusion to
humans.\135\
---------------------------------------------------------------------------
\135\ Prepared statement of Kwai-Cheung Chan, NSVAIR anthrax
hearing (II), p. 17.
---------------------------------------------------------------------------
In any event, DOD does not test military personnel for
antibody levels to determine the extent to which members of a
unit may have acquired protection against anthrax. Uniform
protection is also unlikely because individual immunological
response to the vaccine can vary substantially due to a variety
of factors, including gender, and contemporaneous
administration of other vaccines or medicines.\136\
Nevertheless, DOD concludes enrollment in the AVIP equals
protection for purposes of satisfying the need for uniform
force protection.\137\
---------------------------------------------------------------------------
\136\ Testimony of Col. Renata Engler, Chief, Allergy-Immunology
Service, Walter Reed Army Medical Center, NSVAIR anthrax hearing (IV),
p. 173.
\137\ See supra note 46, p. 1.
---------------------------------------------------------------------------
And, the very factors cited by DOD as necessitating
universal AVIP coverage may actually work against that goal.
Rapid mobility and the mixture of active and reserve forces
mean individuals bring variable levels of protection to their
assignments, depending on the number of shots taken to date and
their individual immune system response. Some people don't
respond to the vaccine at all.\138\ So, beyond the general
proposition that vaccinated individuals are likely to have some
protection against some level of attack, the AVIP will not
assure a commander that a unit is uniformly or even
substantially protected. In tactical terms, the protection
afforded by vaccination would be needed only during the time
between detection and the order to deploy individual and
collective physical protective measures (suits, masks, tents,
et cetera). Better detection capability, improved masks and a
battlefield doctrine to deploy protective measures earlier
could limit or eliminate the need even for that small window of
protection provided by the vaccine.
---------------------------------------------------------------------------
\138\ Investigational New Drug [IND] application for anthrax
vaccine adsorbed [AVA] submitted by Michigan Biologic Products
Institute, Lansing, MI, Sept. 20, 1996, pp. 28-29 (in subcommittee
files).
---------------------------------------------------------------------------
2. The AVIP is vulnerable to supply shortages and price increases. The
sole-source procurement of a vaccine that requires a dedicated
production facility leaves DOD captive to old technology and a
single, untested company. Research and development on a second-
generation, recombinant vaccine would allow others to compete
DOD has built a force-wide program on the narrowest
possible industrial base.
According to GAO, ``The most critical component of the
program, an adequate supply of vaccine, is threatened by
testing delays and possible loss of production capability.''
\139\ Moreover, GAO found ``DOD's plans for maintaining an
adequate supply of vaccine are optimistic . . . and assume that
FDA will grant approval of tested lots in less time than in the
past.'' \140\ Despite the possibility of further delays or a
recurrence of financial problems at BioPort, ``DOD does not
have a formal contingency plan to deal with such
possibilities.'' \141\
---------------------------------------------------------------------------
\139\ See supra note 26, p. 12
\140\ Ibid., p. 5.
\141\ Ibid.
---------------------------------------------------------------------------
When DOD launched the AVIP, subject to the Secretary's four
conditions including supplemental testing, MBPI/BioPort held 40
lots of vaccine, roughly the equivalent of 8 million doses, or
enough vaccine to provide 1.3 million people the full six-shot
regimen (assuming all lots were used before the expiration of
original or extended label dating). But problems in the
supplemental testing program delayed or precluded release of 18
lots.\142\ GAO found:
---------------------------------------------------------------------------
\142\ Ibid., p. 13.
In summary, as of June 23, 1999, only 713,000 doses
in the stockpile were available for use, and more than
half of them--about 416,000 doses--will expire in
February and April 2000. On the basis of DOD's
estimates of doses required per month, the 713,000
doses would sustain phase 1 of the program through
December 1999.\143\
---------------------------------------------------------------------------
\143\ Ibid., p. 15; including an estimated 3-month supply already
delivered to the field at the time of this estimate, GAO concluded the
program could be sustained at best through March 2000.
But even that delayed schedule may be optimistic. FDA
inspectional findings on the renovated facility contain a
number of observations repeated from the February 1998
inspection.\144\ FDA considered those earlier findings
``significant'' and took issue with DOD officials
characterizing cGMP matters as mere ``bookkeeping
difficulties'' in public statements.\145\ If problems with the
renovated facility are determined to be significant enough to
bar release of vaccine lots produced since May 1999,\146\ DOD
could face severe shortages.
---------------------------------------------------------------------------
\144\ FDA Form 483, Nov. 15-23, 1999 (in subcommittee files). See
also, Stars and Stripes, ``Cohen Defends Mandatory Anthrax Shots After
Ordering FDA-Related Suspension,'' p. 1, Dec. 20, 1999.
\145\ E-mails between Food and Drug Administration and Department
of Defense dated Aug. 31-Sept. 1, 1999 (in subcommittee files).
\146\ Production of consistency lots began in the renovated and
expanded BioPort facility in May 1999. Data on consistency lots is
submitted to FDA to validate the production process. Other lots have
also been produced by BioPort in the expanded facility, but use of
those at risk lots depends on FDA approval of the facility license
supplement, an amendment to the license regarding the potency test and
approval of test data on each lot.
---------------------------------------------------------------------------
Because resumption of vaccine production has been delayed
longer than anticipated by plant renovations and efforts to
meet FDA compliance requirements, implementation of phase II of
the AVIP, scheduled to begin in early 2000, has been delayed
``in the range of 6 to 12 months.'' \147\
---------------------------------------------------------------------------
\147\ Dr. Sue Bailey, Department of Defense news briefing, Dec. 13,
1999, p. 2 (available at: http://www.defenselink.mil) (in subcommittee
files).
---------------------------------------------------------------------------
In addition to production problems and delays, BioPort may
not be a reliable financial partner in the vaccine enterprise.
At the subcommittee's request, the General Accounting Office
[GAO] examined the structure and status of the financial
relationship between DOD and BioPort.\148\ They reviewed the
contract documents, proposals and analyses done in connection
with DOD procurement of the anthrax vaccine.\149\
---------------------------------------------------------------------------
\148\ Letter to David Walker, Comptroller General, U.S. General
Accounting Office from Representative Christopher Shays, chairman,
Subcommittee on National Security, Veterans Affairs, and International
Relations, House Committee on Government Reform, May 13, 1999 (in
subcommittee files).
\149\ Contract Management--Observations on DOD's Financial
Relationship with the Anthrax Vaccine Manufacturer, prepared statement
of Louis J. Rodrigues, Director, Defense Acquisition Issues, National
Security and International Relations Division, GAO, GAO/T-NSIAD-99-24,
June 30, 1999.
---------------------------------------------------------------------------
Only 9 months after entering into the agreement, BioPort's
ability to perform under the contract was in doubt.\150\ In
June 1999, the Defense Contract Audit Agency [DCAA] completed
an audit of BioPort's financial condition and reached a similar
conclusion.\151\ According to GAO, estimates contained in
BioPort's business plan and contract proposal have proven
highly optimistic.\152\
---------------------------------------------------------------------------
\150\ Testimony of Louis J. Rodrigues, Director, Defense
Acquisition Issues, National Security and International Affairs
Division, U.S. General Accounting Office, NSVAIR anthrax hearing (III),
p. 4.
\151\ Defense Contract Audit Agency, report No. 2261-97G21000018,
Department of Defense, Sept. 24, 1997 (in subcommittee files).
\152\ Prepared statement of Louis J. Rodrigues, Director, Defense
Acquisition Issues, National Security and International Relations
Division, GAO, NSVAIR anthrax hearing (III), p. 7.
---------------------------------------------------------------------------
As a result, BioPort had to request emergency assistance
from DOD and major modifications to the contract.\153\ In order
to remain able to produce vaccine for the AVIP, BioPort sought
and received an advance payment of $10 million, a significant
per-dose price increase and DOD permission to sell up to
300,000 doses each year on the open market, despite the fact
those doses would be produced using government furnished
equipment under the DOD contract.\154\ DOD also authorized
BioPort's sale of up to 70,000 doses from the vaccine produced
under the prior contract but either released or deemed never
part of the stockpile.\155\
---------------------------------------------------------------------------
\153\ DOD briefing slides, ``BioPort Contract--Anthrax Vaccine,''
June 2, 1999 (in subcommittee files). See also, BioPort Corp. media
release, ``Anthrax Vaccine Manufacturer Calls for Fair and Reasonable
Cotract,'' June 30, 1999 (in subcommitee files).
\154\ Testimony of David R. Oliver, Jr., Principal Deputy Under
Secretary of Defense for Acquisition and Technology, NSVAIR anthrax
hearing (III), p. 65.
\155\ Testimony of David R. Oliver, Jr., Principal Deputy Under
Secretary of Defense for Acquisition and Technology, NSVAIR anthrax
hearing (III), pp. 64-65. See also, DOD briefing slides, ``Anthrax
Vaccine Absorbed Information Brief,'' June 4, 1999 (in subcommittee
files). The briefing contained the following points: ``Ms. Spector
advised that doses in the inventory that have been paid for cannot be
used by BioPort for Private/Foreign Sales'' and ``Release doses from
stockpile for private sales--JPO/OSD action (very political).''
---------------------------------------------------------------------------
This early, extraordinary relief was necessary because
production delays reduced estimated income. And, the
procurement had to be done by means of a fixed price contract
because neither side to the contract knew what it actually cost
to produce the vaccine.\156\ In its transition from a state-
owned facility to a private enterprise, MBPI/BioPort has not
fully implemented promised cost control and cost accounting
systems to support a more appropriate cost-reimbursement
procurement.
---------------------------------------------------------------------------
\156\ Testimony of Louis J. Rodrigues, Director, Defense
Acquisition Issues, National Security and International Relations
Division, GAO, NSVAIR anthrax hearing (III), p. 28.
---------------------------------------------------------------------------
GAO also found the dependent relationship between DOD and
BioPort unusual and risky. While sole-source procurements for
vaccines may be common, those producers usually have other
product lines generating income from other customers. In this
case, problems with the production and delivery of the one
vaccine put the corporation in an extemely bad financial
position.\157\
---------------------------------------------------------------------------
\157\ Ibid., p. 16.
---------------------------------------------------------------------------
One vaccine producer operating a single production site
also points to security risks. GAO observed, ``But if we are
relying upon this vaccine as part of the backbone of our
defensive biological program, the question of vulnerability to
a single site becomes an issue. If you made a decision with
respect to that vulnerability that led you to want to have an
alternative site, then we probably should be looking at
establishing a second source.'' \158\
---------------------------------------------------------------------------
\158\ Ibid., p. 15.
---------------------------------------------------------------------------
Following the Gulf war, and prior to adoption of the DOD
immunization policy (1993) and the mandated AVIP (1998),
Pentagon officials considered and rejected alternative anthrax
vaccine production sites.\159\ Instead, an acquisition strategy
was adopted focusing solely on the MBPI/BioPort vaccine.\160\
---------------------------------------------------------------------------
\159\ See supra note 36, p. 1.
\160\ See supra note 37.
---------------------------------------------------------------------------
Since 1993, DOD has focused almost exclusively on the
older, FDA approved vaccine, to the exclusion of development
work on newer, recombinant vaccine formulations. Not
surprisingly, DOD market surveys detected little interest by
other pharmaceutical or biologics companies in producing the
older anthrax vaccine under a licence from MBPI. So it appears
DOD's sole source justification may be self-validating, in that
there is only one AVA producer because the single largest
vaccine customer has decided to deal with only one producer.
Other manufacturers would be more likely to express an
interest in recombinant vaccine production because it can be
done more safely and efficiently than older vaccine formulation
methods involving live bacteria. But DOD decided not to
emphasize recombinant anthrax vaccine development due to the
lengthy (6 to 8 years) development and approval time, and
potential high costs.
Yet, had DOD officials elected to pursue second-generation
anthrax vaccine development aggressively 6 years ago, they
would be nearing completion on a newer, purer anthrax vaccine.
BioPort's current financial demands, and the company's power to
hold the AVIP hostage in the future, appear to undermine DOD's
determination the MBPI/BioPort acquisition strategy would prove
more affordable than new vaccine development.
One legal review of the BioPort contract sole source
justification suggested DOD add a reference to ways competition
might be increased by utilizing alternative technologies to
produce the anthrax vaccine. The suggestion was not
incorporated in the final document.\161\
---------------------------------------------------------------------------
\161\ Elizabeth Arwine, Legal Advisor, ``Legal Review of
Justification and Approval [J&A;];'' Michigan Biologic Products
Institute [MBPI], Jun. 3, 1997, p. 1 (in subcommittee files). See also,
Joseph S. Little, ``Response to JAG Comments,'' Department of Defense
memorandum for record, June 4, 1997 (in subcommittee files).
---------------------------------------------------------------------------
It appears the choice of the MBPI vaccine for use in the
AVIP may also have been premised on DOD and the manufacturer
obtaining FDA approval to reduce the lengthy shot course from
six shots over 18 months, to just two or three inoculations
over 6 weeks. DOD developed a detailed program to gain approval
for a shortened AVA shot course due to problematic levels of
systemic (0.7 to 1.3 percent) and significant local reactions
(2.4 to 3.9 percent) associated with the prolonged immunization
schedule.\162\ An Investigational New Drug [IND] application
was filed on September 20, 1996 at the FDA to study a reduced
anthrax vaccine shot course, but design of a definitive
comparison study has never been submitted.\163\
---------------------------------------------------------------------------
\162\ See supra note 108.
\163\ Letter from Melinda K. Plaisier, Interim Associate
Commissioner for Legislative Affairs, Food and Drug Administration to
Representative Christopher Shays, chairman, Subcommittee on National
Security, Veterans Affairs, and International Relations, House
Committee on Government Reform, Mar. 15, 1999 (in subcommittee files).
---------------------------------------------------------------------------
So now, having foregone opportunities to improve or
diversify anthrax vaccine production capacity, both DOD and
BioPort are in a fiscal squeeze. Having made a substantial
investment in MBPI and BioPort, DOD now faces hard, costly
choices between sustaining the sole FDA licensed manufacturer
of the anthrax vaccine, which may prove inadequate, and/or
embarking on the establishment and licensure of another. In
future budgets, DOD must consider to fund ``developing a second
source to BioPort or developing a different approach to solve
the anthrax problem and don't take that money and put it
against solving another bio-threat. . . .'' \164\
---------------------------------------------------------------------------
\164\ Testimony of David R. Oliver, Jr., Principal Deputy Under
Secretary of Defense for Acquisition and Technology, NSVAIR anthrax
hearing (III), p. 69.
---------------------------------------------------------------------------
While these alternatives are being reviewed, the mandatory
force-wide program to provide protection against what DOD
characterizes as the pre-eminent biological warfare threat is
on a very uncertain procurement footing. Without more
extraordinary DOD assistance, BioPort appears financially
incapable of capitalizing and sustaining a highly technical,
heavily regulated manufacturing process. The same financial
pressures that hindered MBPI's ability to comply with FDA good
manufacturing practices could also continue to affect BioPort's
capacity to produce a safe and effective product on schedule.
3. The AVIP is logistically too complex to succeed. Adherence to the
rigid schedule of six inoculations over 18 months for 2.4
million members of a mobile force is unlikely, particularly in
reserve components. Using an artificial standard that counts
only shots more than 30 days overdue, DOD tolerates serious
deviations from the Food and Drug Administration [FDA] approved
schedule
No other vaccine required by DOD for force health or combat
protection demands so complex an administration schedule.\165\
The FDA approved inoculation regime is six shots over 18
months, with a subcutaneous injection of AVA to be given as
follows:
---------------------------------------------------------------------------
\165\ See supra note 130.
---------------------------------------------------------------------------
#1--start of series
#2--2 weeks later
#3--1 month after start of series
#4--6 months after start of series
#5--1 year after start of series
#6--18 months after start of series.
Booster--annually after completion of initial
series.\166\
---------------------------------------------------------------------------
\166\ See supra note 41.
---------------------------------------------------------------------------
The ability to track immunizations and meet this schedule
was one of Secretary Cohen's four preconditions to the AVIP.
But even the Secretary of Defense received his fourth
inoculation 3 weeks before it was due.\167\
---------------------------------------------------------------------------
\167\ E-mail from Col. Fred Gerber dated Sept. 1, 1998 (in
subcommittee files).
---------------------------------------------------------------------------
In an effort to comply with the elaborate timetable, DOD
administers a three-tiered recordkeeping system. Each
inoculation should be recorded on the individual service
member's shot record.\168\ Data recorded should include the
date and AVA lot number. The same data is also entered into one
of the service branch medical systems.\169\ Finally, the
service branch systems periodically forward inoculation data to
the Defense Enrollment Eligibility Reporting System [DEERS], a
pre-existing facility modified to serve as an interim access
point for centralized AVIP data. In the future, DOD plans to
centralize AVIP data using an upgrade of the Composite Health
Care System now under development.\170\
---------------------------------------------------------------------------
\168\ Form #PHS-731, Department of Defense (in subcommittee files).
\169\ Service-specific subsystems: the Army MEDPROS, Navy SAMS and
R-STARS, Air Force MITS.
\170\ See supra note 26, p. 10.
---------------------------------------------------------------------------
This system was designed to address problems with medical
recordkeeping encountered during Operation Desert Shield,
Desert Storm, and in Bosnia.\171\ However, while GAO found some
improvements in vaccination records, a sampling of AVIP
tracking at four locations discovered varying levels of
discrepancies between paper and electronic data. According to
GAO:
---------------------------------------------------------------------------
\171\ Ibid., p. 20.
Inconsistency in dates could lead to vaccinations being
given off-schedule and to inaccurate readiness reports.
Inconsistent or missing lot information could hinder
investigations, should concerns arise over a specific
lot. Also, information that is not recorded in paper
records makes it difficult to address adverse reactions
needing immediate care or determine the validity of
subsequent claims for disability compensation.\172\
---------------------------------------------------------------------------
\172\ Ibid., p. 21.
GAO also found use of DEERS data more limited than
anticipated. ``DEERS was envisioned as a major source of
reports on program implementation. However, concerns about the
timeliness and accuracy of data in DEERS have cause service
representatives to rely on interim, service-specific tracking
systems, and other systems to track and report vaccination
information.'' \173\ Specific concerns centered on duty station
data, found in some cases to be updated only 6 to 9 months
late.\174\ This severely limits the utility of DEERS as a tool
to generate unit compliance or readiness reports, since the
database often does not reflect current unit membership.
Readiness estimates based on AVIP tracking data are ``still
suspect,'' according to an internal DOD document.\175\
---------------------------------------------------------------------------
\173\ Ibid., p. 22.
\174\ Ibid.
\175\ E-mails from Maj. Guy Strawder dated Feb. 17, 1999 (in
subcommittee files).
---------------------------------------------------------------------------
The difficulties of tracking anthrax vaccinations in the
active force are compounded in reserve component units,\176\
given changing unit memberships and monthly training schedules
unlikely to match the inoculation regime. This difficulty was
anticipated,\177\ but DOD acknowledged in testimony that
compliance with the FDA inoculation schedule in reserve
component units was lower than in the active force due to less
frequent drill schedules and timing of access to military
medical facilities for purposes of receiving the vaccine.\178\
---------------------------------------------------------------------------
\176\ Reserve components consist of Army, Navy, Air Force, and
Marine reserve units as well as Army and Air National Guard units.
Reserve units are elements of the national military. National Guard
units are state militias unless federalized.
\177\ See supra note 108.
\178\ Prepared statement of Charles L. Cragin, Acting Assistant
Secretary for Reserve Affairs, DOD, NSVAIR anthrax hearing (V), pp. 5-
7; testimony of Charles L. Cragin, NSVAIR anthrax hearing (V), p. 150.
---------------------------------------------------------------------------
As the logistical challenges of vaccine compliance
increase, so do the risks of deviations from the approved
schedule. While the effect of schedule deviations is another
unknown element of the AVIP, DOD concludes ``the greater the
deviation the less certain the protective effect in humans.''
\179\ Nevertheless, ``DOD set a timeliness goal of vaccinating
90 percent of all service members no more than 30 days after
their vaccinations are due. . . .'' \180\ DOD reports meeting
that goal.\181\
---------------------------------------------------------------------------
\179\ Memorandum on ``Policy Deviation from Anthrax Vaccine
Immunization Schedule'' from the Department of Defense dated Sept. 11,
1998, p. 1 (in subcommittee files).
\180\ See supra note 26, p. 24. See also, testimony of Charles L.
Cragin, Acting Assistant Secretary for Reserve Affairs, DOD, NSVAIR
anthrax hearing (V), p. 150.
\181\ Department of Defense, ``Anthrax Vaccine Immunization Program
Quarterly Review,'' Jan. 22, 1999, p. 9 (in subcommittee files).
---------------------------------------------------------------------------
On August 4, 1999, the subcommittee requested data on
vaccine regimen compliance in all reserve component units then
enrolled in the vaccine program. The DEERS reports provided to
the subcommittee contained shot records on 32,681 individuals
who had received one or more inoculations prior to July 31,
1999. Almost half (15,625) the individuals listed were overdue
to receive an inoculation. In some cases, entire units had
missed the schedule by a month or more. A summary of the data
follows:
------------------------------------------------------------------------
Branch/Res. Comp # Enrolled # Overdue % Overdue
------------------------------------------------------------------------
AFReserves....................... 8931 2954 33
AIRNG............................ 9246 2482 27
ArmyNG........................... 2441 1443 59
ArmyReserves..................... 5802 3661 63
MCReserves....................... 2730 1967 72
USNReserves...................... 3531 3118 88 \182\
------------------------------------------------------------------------
The Air Surgeon, Col. James Dougherty, disputed the
accuracy of the DEERS data. In an e-mail reacting to a media
report of poor compliance in a Connecticut Air National Guard
unit, he said ``all the data are inaccurate'' because the DEERS
system is updated weeks after shots are actually
administered.\183\ DOD also said the data showing overdue
inoculations was inflated due to the inadvertent inclusion of
Individual Ready Reserve forces, service members who are
separated from military service but available for call-up.\184\
Nevertheless, according to an internal DOD document, readiness
estimates based on AVIP tracking data are ``still suspect.''
\185\
---------------------------------------------------------------------------
\182\ Letter and accompanying computer diskette from Charles L.
Cragin to Representative Christopher Shays dated Aug. 23, 1999 (in
subcommittee files).
\183\ E-mails from James Dougherty dated Sept. 1, 1999. (in
subcommittee files)
\184\ Testimony of Charles L. Cragin, Acting Assistant Secretary
for Reserve Affairs, NSVAIR anthrax hearing (V), p. 104 (in
subcommittee files).
\185\ See supra note 175.
---------------------------------------------------------------------------
If the centralized tracking system cannot provide a real-
time picture of the inoculation status of the entire force, or
individual units, it fails to meet the operational standard set
by the Secretary as a condition of AVIP implementation.
The data provided to the subcommittee by DOD also showed
most reserve component members receive the first three
inoculations on schedule, with compliance deviations occurring
with regard to subsequent shots.\186\ That may not be entirely
inadvertent. DOD documents contain the statement ``Soldiers
with 3 or more vaccinations are Protected.'' \187\ The DOD
position that ``functional protection'' \188\ is provided after
only three of the six required inoculations sets a
deployability standard against which reserve component
commanders are measured. Once members of a unit have received
three shots, there appears to be little incentive to press for
further compliance with an increasingly unpopular program.
---------------------------------------------------------------------------
\186\ See supra note 182.
\187\ See supra note 134, p. 2, and e-mails from Department of
Defense personnel dated Feb. 17-Apr. 14, 1999 (in subcommittee files);
If the manufacturer of a pharmaceutical or biologic product advised
patients or physicians that half the FDA approved dosage or
administration regimen was as effective against the labeled indication,
it would be a serious violation of FDA regulations.
\188\ See supra note 134, p. 2.
---------------------------------------------------------------------------
There is little scientific evidence to support the theory
that three shots protect as well as six. DOD expended
significant time and resources in 1994 and 1995 on plans and
programs to demonstrate the safety and efficacy of a shorter
anthrax inoculation regime, and a different route of
administration. An Investigational New Drug [IND] application
was filed to guide further animal studies and clinical trials
in humans. But the effort appears to have all but abandoned
when planning for the AVIP began. Support for the FDA
application to reduce the shot course seems to have been
redirected to vaccine acquisition and AVIP logistics.
In September 1999, the Director of the FDA Center for
Biologics Evaluation and Research, Dr. Katherine Zoon, wrote to
Dr. Sue Bailey, Assistant Secretary of Defense for Health
Affairs regarding data showing significant deviations from the
AVA administration routine:
. . . Because we are unaware of any data demonstrating
that any deviation from the approval intervals of doses
found in the approved labeling will provide protection
from anthrax infection, we strongly recommend that the
Anthrax Vaccine Immunization Program follow the FDA
approved schedule.\189\
---------------------------------------------------------------------------
\189\ Letter from Dr. Katherine C. Zoon to Dr. Sue Bailey dated
Sept. 29, 1999 (in subcommittee files).
Prior to the administration of each shot, medical personnel
are directed to provide information on the vaccine and the
program, and to inform each recipient regarding the health
factors that should exclude a person.\190\ Exclusionary factors
include severe reaction to a previous shot, active infection,
pregnancy, current immuno-suppression.\191\ Service members
should also be informed regarding the identification and
reporting of adverse health events suffered subsequent to
inoculation.\192\
---------------------------------------------------------------------------
\190\ See supra note 46, p. C-5.
\191\ See supra note 41.
\192\ Department of Defense, ``Clinical Practice Guidelines for
Managing Adverse Events After Anthrax and Other Vaccinations,'' Nov.
15, 1999 pp. 1-2. (in subcommittee files).
---------------------------------------------------------------------------
But GAO found medical staff and service members were not
well informed about reporting adverse events and found more
than 40 percent of those sampled had not received information
on how to report vaccine related adverse events.\193\ Testimony
by service members reflected the GAO findings.
---------------------------------------------------------------------------
\193\ See supra note 26, pp. 24-26.
---------------------------------------------------------------------------
Ms. Randi Martin-Allaire, a civilian employee of the
Michigan Air National Guard told the Subcommittee, ``I was on
antibiotics at the time I received my fourth injection, and was
never asked if I was on any type of medication or
antibiotics.'' \194\ Her colleagues described similar miscues
and confusion over the standards for identifying and treating
vaccine adverse reactions.\195\
---------------------------------------------------------------------------
\194\ Prepared statement of Randi J. Martin-Allaire, NSVAIR anthrax
hearing (II), p. 170.
\195\ Prepared statement of Roberta Groll, NSVAIR anthrax hearing
(II), pp. 176-179; and prepared statement of David Churchill, NSVAIR
anthrax hearing (II), pp. 183-188.
---------------------------------------------------------------------------
Service members report AVIP information and briefings seem
designed to persuade, not educate. The inability of Air Force
briefers to answer service members' questions led one commander
to suspend the vaccination program until the Air Force Surgeon
General personally intervened.\196\ Vaccine recipients also
report mass inoculations during which no questions regarding
current health status are asked and no VAERS forms made
available.\197\
---------------------------------------------------------------------------
\196\ Debra Funk, ``Air Guard Unit Delays Anthrax Inoculations,''
Air Force Times, July 5, 1999, p. 29.
\197\ E-mails and meeting notes (in subcommittee files).
---------------------------------------------------------------------------
The AVIP is made more complex by the need to address
growing resistance to the vaccine, specifically in reserve
component units. The impact of the AVIP on retention in reserve
component units could be significant. Informal surveys by
service members suggest the Air National Guard may suffer air
crew attrition of 30 percent or more.\198\ To date, the Defense
Department has not acknowledged any unusual pattern of
resignations attributable to the AVIP.\199\
---------------------------------------------------------------------------
\198\ See supra note 74.
\199\ Testimony of Maj. Gen. Paul Weaver, Director, Air National
Guard, DOD, NSVAIR anthrax hearing (V), p. 118.
---------------------------------------------------------------------------
It is not clear where the Department might look to discern
such a pattern. DOD collects no centralized data on refusals or
resignations attributable to the vaccine program. Some service
members also said unit commanders openly discouraged
attribution of resignations or transfers to the AVIP.\200\ An
Air Force Reserve Interim Anthrax Policy forbids the approval
of transfer requests made by anyone scheduled or directed to
begin the anthrax immunizations.\201\
---------------------------------------------------------------------------
\200\ E-mails (in subcommittee files).
\201\ Command Anthrax Policy, U.S. Air Force Reserve, June 22, 1999
(in subcommittee files).
---------------------------------------------------------------------------
GAO was critical of this lack of monitoring to determine
the effectiveness of the AVIP communications effort.\202\
Without data on refusals, ``it is difficult to better target
educational efforts and address emerging concerns. These
problems need to be resolved if the program is to succeed in
vaccinating the entire force against anthrax.'' \203\ (emphasis
added)
---------------------------------------------------------------------------
\202\ See supra note 26, p. 35.
\203\ Ibid.
---------------------------------------------------------------------------
To address the logistical challenges of the current
immunization schedule, and to reduce the number of exposures to
a ``reactogenic'' \204\ vaccine, DOD developed a detailed
program to gain approval for a shortened AVA shot course, but
FDA approval has not been pursued.
---------------------------------------------------------------------------
\204\ See supra note 108.
---------------------------------------------------------------------------
4. Safety of the vaccine is not being monitored adequately. The program
is predisposed to ignore or understate potential safety
problems due to reliance on a passive adverse event
surveillance system and DOD institutional resistance to
associating health effects with the vaccine
Based on data gathered during limited occupational use
since licensure, the AVA can be considered nominally safe. But
the vastly expanded use of the vaccine for a new purpose
requires a proactive approach to emerging safety issues. That
approach is not now a part of the AVIP.
As with any vaccine, anthrax inoculation can cause adverse
health events in some individuals, ranging from soreness or
swelling at the injection site (local reactions) to fevers,
chills, muscle aches, and anaphylaxis \205\ (systemic
reactions). Local reaction may be mild, moderate, or severe
enough to require medical attention. Systemic reactions are
generally considered clinically more significant. Reactions may
increase in severity after successive injections.\206\
---------------------------------------------------------------------------
\205\ Hypersensitivity to a drug or antigen. Anaphylactic shock is
an often severe, sometimes fatal, physical reaction characterized by
respiratory symptoms, fainting, swelling, and itching.
\206\ See supra note 41.
---------------------------------------------------------------------------
More inoculations mean more reactions. An immunization
program using a vaccine requiring six shots and annual boosters
should be prepared to deal with some number and variety of
adverse health effects. Despite having been licensed for almost
30 years, the vaccine had not been widely used prior to the
Gulf war.\207\ As noted previously, lack of adequate medical
recordkeeping prevents systematic study of that cohort for
health effects possibly associated with the anthrax vaccine and
other medicines and toxins. The vaccine is being studied as a
potential factor in Gulf war veterans' illnesses.\208\ As GAO
noted, ``The long term safety of the vaccine has not yet been
studied.'' \209\
---------------------------------------------------------------------------
\207\ Prepared statement of Kathryn C. Zoon, Ph.D., NSVAIR anthrax
hearing (II), pp. 52-53.
\208\ See supra note 1.
\209\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Relations Division, GAO, NSVAIR anthrax hearing (II), p. 11.
---------------------------------------------------------------------------
The AVA has been described as a relatively crude,
imprecisely characterized vaccine, and estimates of reaction
rates vary widely.\210\ According to the FDA-approved AVA
product labeling, 30 percent of vaccine recipients can be
expected to suffer mild local reactions, 4 percent will incur
moderate local reactions, and less than 0.2 percent will
experience systemic reactions.\211\ In 1994 and 1995, DOD
considered the need for a new anthrax vaccine ``based on the
reactogenicity of the current vaccine.'' \212\
---------------------------------------------------------------------------
\210\ Ibid., p. 16.
\211\ See supra note 41.
\212\ ``Minutes of FDA Meeting of 5 May 94 Concerning Production
and Purification of PA from Delta Sterne,'' Department of the Army, May
19, 1994, p. 1.
---------------------------------------------------------------------------
In April 29, 1999 testimony \213\ before the subcommittee,
the General Accounting Office [GAO] summarized studies of
anthrax vaccine reactions, finding rates of systemic reactions
ranging from 0.05 percent to 48 percent. (Table 1, below).
---------------------------------------------------------------------------
\213\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Relations Division, GAO, NSVAIR anthrax hearing (II), p. 16.
Table I: Reactions to Licensed Anthrax Vaccine Reported in Various Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local reactions (percent) Systemic reactions (percent)
Type of Number ---------------------------------------------------------------
Study Reporting Vaccinated (or Moderate/ Moderate/
doses) Mild Severe Mild Severe
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND..................................................... Active/Passive 3,984 a 6-20 b 1-10 b None b 0.05 b
Pittman (1997).......................................... Active 508 16 5 29 c 14
TAMC (1998)............................................. Active 536 Not Addressed Not Addressed 43 d 5
DOD (Current monitoring)................................ Passive 223,000 e e e e e
--------------------------------------------------------------------------------------------------------------------------------------------------------
a This number represents the number of study participants who received the first dose of the licensed vaccine.
b These figures represent the percentage of people who experienced this type of reaction during the study, even if they had previously been inoculated
with the Merck vaccine.
c This figure also includes persons who had reactions of ``unknown'' severity.
d This figure represents the frequency of the most common side effect, myalgia.
e DOD testified that as of Mar. 16, 1999, more than 223,000 service members have been immunized. There had been 42 reports on adverse effects submitted
to the FDA and CDC. Only seven service members required hospitalization or experienced loss of duty for more than 24 hours.
In later testimony, GAO also observed:
In addition to reporting to VAERS, DOD has conducted
three efforts to actively collect data on adverse
reactions after service members received the anthrax
vaccine. Data from these efforts show that women
reported twice the rate of adverse reactions than men
for both local (e.g. swelling) and systemic (e.g.
malaise and chills) reactions. In addition, a higher
proportion of women than men reported making an
outpatient medical visit after a vaccination, and more
than twice the percentage of women reported that they
missed one or more duty shifts after their vaccinations
than did men.\214\
---------------------------------------------------------------------------
\214\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Relations Division, GAO, NSVAIR anthrax hearing (IV), p. 3 (in
subcommittee files).
Captain Michelle L. Piel believes she suffered an adverse
reaction to the anthrax vaccine. Fatigue, dizziness, joint pain
and severe cold-like symptoms following her first two
inoculations resulted in the loss of flight status. When she
suggested submitting a report to VAERS, she testified, ``My
request met reluctance.'' \215\ Because her symptoms did not
fall within the range of expected vaccine reactions, doctors as
Dover Air Force Base did not associate her illness to the AVA.
She concluded, ``This is a major reason why adverse events from
the anthrax vaccine are underreported.'' \216\ She added,``It
didn't make sense to me. I was too sick to fly. I was too sick
to get another shot. But my illness wasn't reportable on a
VAERS form?'' \217\
---------------------------------------------------------------------------
\215\ Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax
hearing (IV), p. 3 (in subcommittee files).
\216\ Ibid.
\217\ Ibid.
---------------------------------------------------------------------------
When others at Dover suspected health effects might be
linked to the vaccine, efforts to report a trend ``were met
with resistance and discouragement from within Dover's medical
community.'' \218\ According to Capt. Piel, ``It took 6 months
to reach the right, highly specialized doctors to begin to
diagnose my immune system problems.'' \219\
---------------------------------------------------------------------------
\218\ Ibid.
\219\ Ibid., p. 4.
---------------------------------------------------------------------------
At the reaction rates cited by the U.S. Army Medical
Research Institute of Infectious Diseases [USAMRIID],\220\ the
anthrax vaccine program, when implemented across the entire 2.4
million member force, could produce 31,200 systemic reactions
and up to 93,600 severe local reactions. Recently, the Army
Surgeon General conceded that, ``Systemic events occur in 5 to
35 percent of anthrax-vaccine recipients.'' \221\ At the range
of systemic reactions found by DOD in the Tripler Army Medical
Center active surveillance study, the AVIP could generate over
1 million systemic reactions, many thousands of which will
require medical management and treatment.\222\
---------------------------------------------------------------------------
\220\ See supra note 108.
\221\ Letter from Lt. Gen. Ronald R. Blanck to Mark Zaid dated Dec.
10, 1999, p. 1 (in subcommittee files).
\222\ See supra chart at note 213.
---------------------------------------------------------------------------
Given that prospect, it might have been expected by service
members that an integral part of the AVIP would be highly
sensitive active and passive surveillance systems to ``permit
accurate assessments of types and severity of adverse
reactions'' \223\ because ``only widespread use can provide
this assessment.'' \224\ That was one factor which lead DOD to
indemnify the vaccine manufacturer against the ``unusually
hazardous risks'' of vaccine production.\225\
---------------------------------------------------------------------------
\223\ See supra note 33.
\224\ Ibid.
\225\ Ibid.
---------------------------------------------------------------------------
To better quantify those risks, and to detect adverse
reaction trends early, the program design could have included
detailed medical protocols on screening, vaccine
administration, and adverse events. The AVIP could have
assembled and trained a multi-disciplinary network of health
professionals to manage the anticipated adverse event caseload.
It could have provided each recipient with a simple, one page
vaccine information sheet on adverse events and drug inter-
actions of the type routinely provided with childhood vaccines.
The AVIP could have designed and initiated the controlled,
cohort studies only now being discussed to learn more about
reaction rate differences by age and gender.\226\
---------------------------------------------------------------------------
\226\ Deborah Funk, ``Military Officials Order Study to Determine
Vaccine's Safety, Long-term Side effects,'' Army Times, July 12, 1999,
p. 12.
---------------------------------------------------------------------------
The AVIP does not include those safety elements.
Instead, the program now relies primarily on an adverse
event surveillance and reporting system known to understate the
nature and extent of health effects associated with vaccine
administration. Access to immunologists and allergists is
limited geographically. Not until 1 year after the program
began did DOD update briefing materials to include information
on reporting adverse events and revise program regulations to
make reporting requirements more inclusive, clarify patient and
provider responsibilities, and explain how to process a Vaccine
Adverse Event Reporting System [VAERS] form. Only in July 1999
did DOD distribute draft clinical guidelines that outline
clinical protocols, pre-treatments, specialty referral
processes, contraindications, categorizations of local and
systemic reactions, and associated treatment algorithms.\227\
---------------------------------------------------------------------------
\227\ Prepared statement of Maj. Gen. G. Robert Claypool, Deputy
Assistant Secretary for Health Operations Policy, DOD, NSVAIR anthrax
hearing (IV), p. 12 (in subcommittee files).
---------------------------------------------------------------------------
According to GAO testimony, studies have shown passive
systems sometimes capture only 1 percent of adverse events
temporally or causally related to use of a medical device or
vaccine. Reports also vary in quality and utility due to
inconsistencies in identifying and interpreting health effects
as vaccine related. A passive system is useful as a
``sentinel'' to alert clinicians to unexpected events.\228\
``It does not tell you how often, with what severity, or does
not establish causality. The limitations are very well
accepted.'' \229\
---------------------------------------------------------------------------
\228\ Testimony of Kwai-Cheung Chan, Director, Special Studies and
Evaluation Section, National Security and International Relations
Division, GAO, NSVAIR anthrax hearing (IV), p. 125 (in subcommittee
files).
\229\ Testimony of Dr. Shushil K. Sharma, Special Studies and
Evaluations Section, National Security and International Relations
Division, GAO, NSVAIR anthrax hearing (II), p. 25.
---------------------------------------------------------------------------
Because passive systems are voluntary, the data generated
are subject to a self-selection bias, in that trends in
volunteered data cannot be extrapolated as if representative of
an entire cohort or population. As a result, information from a
passive reporting system, like VAERS, is not an appropriate
source of data for use in generating adverse reaction rates.
Nevertheless, AVIP reports and DOD public statements
portray the ratio of VAERS reports to inoculations given as an
adverse reaction rate.
In presenting reaction rate data, program and DOD
officials have shown reactions reported to VAERS as a
percentage of all vaccinations. They did so in several
briefings to GAO and congressional staff, in prepared
testimony, and on the program's Internet site. However,
according to FDA guidance, incidents in the VAERS
database reflect a temporal, not necessarily a causal,
relationship with vaccination and thus should not be
used to calculate the incidence of reactions.\230\
---------------------------------------------------------------------------
\230\ See supra note 26, p. 32.
GAO found, ``This is misleading because of potential
underreporting of events to VAERS, and the potential for
overstating the reaction rate because reports sent to VAERS are
not confirmed to be causally linked to the vaccination.'' \231\
The potential for overreporting is limited, however, by DOD
screening of VAERS reports before inclusion in quarterly AVIP
figures. In this regard, GAO concluded, ``Thus, DOD does not
have reliable information on the extent of adverse reactions.''
\232\
---------------------------------------------------------------------------
\231\ Ibid.
\232\ Ibid.
---------------------------------------------------------------------------
Even if useful to gauge short term reactions, passive
reporting systems are also unlikely to capture long term or
chronic health effects or syndromes, since providers and
vaccine recipients do not generally associate an illness with
an event far removed in time.\233\ But many service members are
concerned over possible long term health effects of the anthrax
vaccine, alone or in combination with other treatments and
exposures.\234\ According to GAO, ``A primary reason for
dissatisfaction with information about long-term side effects
appears to be that research has not been done to address the
topic. According to program officials, such studies have
recently been discussed but are not yet funded or underway.''
\235\
---------------------------------------------------------------------------
\233\ Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing
(II), p. 107.
\234\ Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax
hearing (IV) (in subcommittee files); prepared statement of Capt. Jon
Richter, NSVAIR anthrax hearing (IV) (in subcommittee files); and e-
mails sent to the subcommittee (in subcommittee files).
\235\ See supra note 26, p. 32.
---------------------------------------------------------------------------
The AVIP's strict VAERS reporting requirements of
hospitalization or more than 24 hours absence from duty limit
the scope of any safety surveillance to severe, short term
reactions. This overly narrow interpretation of adverse event
data could result in DOD missing the types and severity of
adverse reactions only widespread use would otherwise reveal.
The ``statistical significance of a predicted adverse
reaction'' \236\ will only become apparent if the statistics
are permitted to capture the full range of available data.
---------------------------------------------------------------------------
\236\ See supra note 30.
---------------------------------------------------------------------------
A system already known for underreporting can be made even
less reliable in the hands of an institutional culture
resistant, even hostile, to reports attributing ill health to
the anthrax vaccine. Air Force Lieutenant Richard Rovet, while
serving as Health Care Integrator for the Flight Medicine
Clinic at Dover AFB, noted a number of individuals reporting
potentially vaccine-related symptoms: dizziness, ringing in the
ears, joint pain, muscle aches, memory impairment, fatigue,
numbness, prolonged fever and chills, localized and persistent
rashes.\237\ He said there was significant confusion in the
field regarding reportable reactions ``especially in regard to
what constitutes systemic reaction.'' \238\ Lt. Rovet testified
medical providers saw the issue of identifying vaccine
reactions ``politically sensitive and like to avoid it.'' \239\
---------------------------------------------------------------------------
\237\ Prepared statement of Lt. Richard Rovet, NSVAIR anthrax
hearing (IV), p. 2 (in subcommittee files).
\238\ Testimony of Lt. Richard Rovet, NSVIAR anthrax hearing (IV),
p. 25 (in subcommittee files).
\239\ Ibid.
---------------------------------------------------------------------------
That resistance reduces what few incentives already
motivate military personnel to report sick. Particularly when
complaining of symptoms of unknown origin, a service member
risks the label ``malingerer'' or ``depressed.'' \240\ If
seeking care seems a dead end, ``why risk your flying status if
you are just suffering some of the mild symptoms of joint pain
or you feel a little bit tired? Why should you go to the doctor
if you feel you can continue to operate an airplane? And that
is why people don't come forward.'' \241\
---------------------------------------------------------------------------
\240\ Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax
hearing (IV) p.3 (in subcommittee files).
\241\ Testimony of Capt. Michelle L. Piel, NSVAIR anthrax hearing
(IV), p. 59 (in subcommittee files).
---------------------------------------------------------------------------
An Air Force Reservist, Capt. Jon Richter, also suffered
chronic symptoms he attributed to the vaccine. While he came
forward, he testified there is little incentive for others do
so. ``I was encountering more of my squadron mates who were
vaccinated that said they too had experienced various
reactions, including tinnitus, dizziness, muscle and joint
pain, and, in one case, gray-outs. However, most were
attempting to keep it low profile and did not readily discuss
these matters for fear of reprisal.'' \242\ ``Word travels
fast. Morale is at an all time low. People are trigger shy
about coming forward with their symptoms. There is an air of
fear and distrust prevalent throughout.'' \243\
---------------------------------------------------------------------------
\242\ Testimony of Capt. Jon Richter, NSVAIR anthax hearing (IV),
p. 38 (in subcommittee files).
\243\ Ibid, p. 41.
---------------------------------------------------------------------------
A reluctance to acknowledge vaccine related health effects
could also block access to the immunologists and allergists
experienced in the diagnosis and treatment of adverse
reactions. This can be a more acute problem for National Guard
and Reserve members whose level of access to military medicine,
particularly specialists, for vaccine matters is uncertain.
Witnesses at the subcommittee's April 29 hearing from the
Michigan Air National Guard described a difficult and time
consuming process to gain access to medical personnel with
relevant expertise.\244\
---------------------------------------------------------------------------
\244\ Prepared statement of Roberta Groll, NSVAIR anthrax hearing
(II), pp. 176-179; prepared statement of Randi Martin-Allaire, NSVAIR
anthrax hearing (II), pp. 167-171; and prepared statement of David
Churchill, NSVAIR anthrax hearing (II), pp. 183-188.
---------------------------------------------------------------------------
According to the Dr. Renata Engler, Chief Immunologist at
the Water Reed Army Medical Center, and a consultant to the
AVIP, ``Vaccine administration is serious business and deserves
more care and training of those who deliver the service.''
\245\ One critical issue, she said, ``is that stakeholders who
understand the clinical issues have NOT been represented in the
organizational policy development.'' \246\ ``There is a problem
that the organization does NOT have a forum for experienced,
ongoing clinical input into the many problems that surround
immunization delivery and adverse reaction management.'' \247\
(Emphasis in original).
---------------------------------------------------------------------------
\245\ E-mails from Col. Renata Engler dated Dec. 4, 1998 (in
subcommittee files).
\246\ E-mail from Col. Renata Engler dated Dec. 15, 1998 (in
subcommittee files).
\247\ Ibid.
---------------------------------------------------------------------------
Those problems include recognition of potentially life-
threatening hypersensitive reactions, use of pre-treatments to
mitigate vaccine reactions and the criteria to be applied to
determine temporary or permanent medical exemption, or waiver,
from the AVIP. At the first DOD conference on biological
warfare immunizations, held in May 1999, Dr. Engler made a
presentation on the clinical challenges posed by the AVIP. She
summarized several case studies of those who had suffered
adverse reactions to the anthrax vaccine, with data from Walter
Reed Army Medical Center, data from Dr. Hoffman's study in
Korea, and patient profiles from Dover AFB.\248\ In her slide
presentation, she noted a ``fear of military medical
establishment'' and concluded the AVIP message should be,
``Every service member deserves the same quality of care as ANY
OTHER PATIENT: investigate problems proactively & objectively,
validate suffering, knowledge base and unknowns. Vaccines are
drugs & NOT 100% safe.'' \249\
---------------------------------------------------------------------------
\248\ See supra note 51, pp. 3-7.
\249\ Ibid., p. 12.
---------------------------------------------------------------------------
Regarding the availability of medical deferrals and
waivers, Dr. Engler asked, ``Should medical waivers become a
punitive event? . . . Do we want rigid administrative
guidelines that polarize and antagonize service members with
problems? Can we acknowledge risk & include choice of affected
AD in final disposition? Does every service member have to be
immunized or is there room for a benefit risk ratio
discussion?'' \250\
---------------------------------------------------------------------------
\250\ Ibid.
---------------------------------------------------------------------------
Room for that discussion may be limited. The risk/benefit
decision underlying the AVIP can conflict with the clinician's
duty to weigh the risks and benefits to the individual patient.
In an e-mail exchange with Col. Fred Gerber, operational head
of the AVIP, Dr. Engler posed the following example:
A rash within 2 hours of the vaccine could represent an
increased risk for life threatening anaphylaxis with
next dose--if you ignore this and do not handle it
appropriately and a subsequent dose results in
significant harm, you are outside the standard of care
and would NOT be excused by the ``active duty''
blanket. Our specialty has worked with this type of
patient and achieved successful and safe subsequent
vaccination but this requires expertise and very
carefully prepared informed consent. ETHICALLY, you
cannot expose a soldier to a medical treatment if he/
she is at increased risk for harm from it and yes we do
waiver people for serious vaccine reactions from future
reactions and they continue on active duty for the most
part. Anthrax brings unique urgency to the scenario and
a group discussion on these issues with an ethicist is
crucial.\251\ (Emphasis in original).
---------------------------------------------------------------------------
\251\ See supra note 245.
Col. Gerber, while disclaiming any purview over clinical
issues, was unwilling to acknowledge that safety considerations
might need to overcome the AVIP imperative in some number of
---------------------------------------------------------------------------
cases:
Not sure I agree with what you've presented Renata. If
. . . she had a rash within 2 hrs of shot #1 . . .
[w]hy would that exempt her from getting rest of series
and going to Korea? Who should go in her place? Those
become the issues. Korea is one of the two AVIP Phase I
High Threat Areas . . . everyone is at increased risk
for exposure to anthrax there. By your algorithm, when
we get to Phase II of the AVIP, new soldiers coming
into service would be put out of service because of an
adverse reaction to anthrax . . . what about an adverse
to any of the other 17 immunizations? . . . Call it
like you see it, but I wouldn't quickly exempt soldiers
from worldwide assignments who have rashes, pain,
swelling, etc. Let's face it, AVA is one of many
soldiers have to take. The more exotic vaccines are yet
to come. . . . Does a rash in 2 hours mean you can't
get any more immunizations without additional clinical
follow-up/eval? I'm not sure it does.\252\
---------------------------------------------------------------------------
\252\ E-mails from Col. Fred Gerber dated November 17, 1998 (in
subcommittee files).
Concerns about the short and long term safety of the
anthrax vaccine are legitimate. It is disingenuous for DOD to
say 30 years of use have seen no serious short-term or chronic
adverse health effects associated with the vaccine. For most of
that time, no one was looking.
The short-term adverse reaction rates contained in the FDA-
approved labeling were derived from data gathered during
testing of an earlier, less reactogenic anthrax vaccine. FDA
only established the Vaccine Adverse Event Reporting System in
1990. That passive surveillance system, while useful to detect
sentinel events or clusters for further study, understates the
extent of reactions. Limited use of the vaccine since licensure
has yielded limited information that suggests higher reaction
rates, particularly in women.\253\
---------------------------------------------------------------------------
\253\ ``Anthrax Vaccine: Safety and Efficacy Issues,'' (GAO/NSAID-
00-48) U.S. General Accounting Office, Oct. 12, 1999, pp. 1-7.
---------------------------------------------------------------------------
Since the AVIP began, DOD has undertaken two active follow-
up surveys of vaccine recipients, one in Korea and another at
Tripler Army Medical Center, Hawaii. The results of both
studies indicates both local and systemic reactions at
generally higher rates than described in the product labeling.
According to GAO, ``The data gathered in Korea also show that
after the first two shots, more than twice the proportion of
women than men reported systemic reactions of fever, malaise,
or chills than did men.'' \254\ The Tripler survey also
demonstrates gender differences in reported reactions.\255\
---------------------------------------------------------------------------
\254\ Ibid., p. 3.
\255\ Ibid., p. 4.
---------------------------------------------------------------------------
Service members' concerns about the impact of manufacturing
process lapses on vaccine quality and safety are well placed.
For biological products, the process is the product.
``[Q]uality cannot be guarantees from final tests on random
samples but only from a combination of in-process tests, end-
product tests, and strict controls of the entire manufacturing
process.'' \256\ At BioPort, and its predecessor the Michigan
Biologics Products Institute, those controls were found to be
less than strict.
---------------------------------------------------------------------------
\256\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Affairs Division, GAO, NSVAIR anthrax hearing (II), p. 13.
---------------------------------------------------------------------------
The long-term safety of the licensed vaccine has not been
studied.\257\ It is of little comfort to service members that
no other vaccines have been subject to any post-licensure
longitudinal study. Unlike more modern vaccines, the AVA was
approved before animal toxicity studies were even required. As
a result, ``studies have not been performed to evaluate the
effect of AVA on carcinogenesis, mutagenesis or impairment of
fertility. Animal reproduction studies have not been conducted
with AVA. Neither is it known whether AVA can cause fetal harm
when administered to a pregnant woman or whether it can affect
reproductive capacity.'' \258\
---------------------------------------------------------------------------
\257\ Ibid., p. 11.
\258\ See supra note 138, pp. 87-88.
---------------------------------------------------------------------------
It is unlikely the current anthrax would be approvable
under modern regulatory standards for the safety and efficacy
of biological products. It seems unlikely BioPort will be able
to achieve and sustain modern manufacturing standards for safe
vaccines.
5. Efficacy of the vaccine against biological warfare is uncertain. The
vaccine was approved for protection against cutaneous (under
the skin) infection in an occupational setting, not for use as
mass protection against weaponized, aerosolized anthrax
Uncertainties about safety might be more readily accepted
if there were no questions about the effectiveness of the
anthrax vaccine. Safety risks would be tolerable if the
benefits were unquestioned. But there are questions. The
proposition that the AVA will provide effective protection
against the most likely form of weaponized anthrax, aerosolized
spores in significant quantities, is unproven.
And, until there is an anthrax attack, the proposition must
remain unproven. The industrial settings in which anthrax was a
threat have all but disappeared.\259\ It would be unethical to
expose human test subjects to a lethal agent. So, based on
proven efficacy against indeterminate levels of cutaneous
exposure in an industrial setting, it can only be assumed the
vaccine provides equivalent protection against high levels of
inhalation exposure.
---------------------------------------------------------------------------
\259\ Only research and testing facilities now present an
occupational setting posing a danger of anthrax exposure.
---------------------------------------------------------------------------
That assumption is supported by data from tests on
vaccinated animals who survive aerosol challenge. But different
survival rates between animal species, and between anthrax
strains, raise more questions than the vaccine answers about
the actual physiological mechanism of protection. Without a way
to correlate animal data to human protection (i.e., PA antibody
titers), efficacy of the vaccine may never be more than
suggested or inferred.
According to GAO:
Studies on the efficacy of anthrax vaccine have been
limited to a study of the efficacy of the earilier
version for humans and studies of the efficacy of the
licensed vaccine for animals. The only study of the
efficacy of the vaccine for humans was performed by
Brachman, using the original vaccine. The Brachman
study claimed that the vaccine gave 93 percent (and a
lower confidence limit of 65 percent) protection
against anthrax penetrating the skin. It found that the
number of individuals who contracted anthrax by
inhalation was too low to assess the efficacy of the
vaccine against this form. There has been no specific
study of the efficacy of the licensed vaccine in
humans. Rather, its efficacy in humans has been
inferred from other data, including a reduction in the
incidence of anthrax following immunization of at-risk
individuals and from animal experiments.\260\
---------------------------------------------------------------------------
\260\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Affairs Division, GAO, NSVAIR anthrax hearing (II), pp. 16-17.
All the DOD animal studies support the view that the
licensed vaccine can protect some animals against exposure to
some strains of anthrax either by inoculation or inhalation.
But animal species differ in susceptibility.\261\ In testimony
submitted to the subcommittee, Dr. Meryl Nass summarized the
available data from animal studies of anthrax vaccine efficacy.
``One can see varying survival rates from 0-100% depending upon
the strain of anthrax used and possibly other parameters of the
experiment. Survival rates in guinea pigs varied from 23% to
71% when they were exposed to inhaled anthrax.'' \262\ Studies
in mice showed survival rates between no higher than 10
percent.\263\
---------------------------------------------------------------------------
\261\ See supra note 253, p. 8.
\262\ Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing
(II), p. 108.
\263\ Ibid., p. 110.
---------------------------------------------------------------------------
In concluding the current vaccine is effective against
aerosol challenge, DOD relies primarily on studies using rhesus
monkeys. ``These animal studies showed that the FDA-approved
anthrax vaccine provided greater than 95% protection against
high-dose aerosol challenge with anthrax in the monkey model.
Human antibody response to the FDA-licensed vaccine provides
further suggestive evidence that the FDA-licensed anthrax
vaccine will protect against inhalation anthrax.'' \264\
---------------------------------------------------------------------------
\264\ Prepared statement of Dr. Sue Bailey, Assistant Secretary for
Health Affairs, DOD, NSVAIR anthrax hearing (I), p. 11.
---------------------------------------------------------------------------
But, according to GAO, ``several studies have shown no
direct comparison of immunity in humans to that in monkeys.''
\265\ In fact, the one immunized monkey that died in the DOD
studies ``had a low antibody titer similar to other monkeys
that lived following a lethal aerosol challenge.'' \266\
---------------------------------------------------------------------------
\265\ U.S. General Accounting Office, Correspondence to
Representative Steve Buyer from Kwai Cheung-Chan, ``Summary of GAO's
Findings on the Safety and Efficacy of the Anthrax Vaccine,'' (GAO-
NSIAD-00-54R), Nov. 4, 1999, p. 3.
\266\ See supra note 138, p. 90.
---------------------------------------------------------------------------
One study comparing the efficacy of a live spore vaccine to
a PA-based vaccine, like the AVA, concluded, ``Immunization
with cell-free preparations which contained components of that
anthrax toxin did not provide adequate protective response
against some challenge isolates of B. anthracis. The fact that
the spore vaccine provided protection against all isolates
tested suggests that other antigens may play a role in active
immunity.'' \267\
---------------------------------------------------------------------------
\267\ Stephen F. Little and Gregory B. Knudson, ``Comparative
Efficacy of Bacillus anthracis Live Spore Vaccine and Protective
Antigen Vaccine against Anthrax in the Guinea Pig,'' Infection and
Immunity, May 1986, vol. 52, No. 2, p. 511.
---------------------------------------------------------------------------
DOD resists that suggestion because confidence in the
efficacy of the current anthrax vaccine in humans, against all
known strains, depends heavily on the conclusions 1) that the
antibody response to the one antigen, PA,\268\ protects against
the toxic mechanism of all natural anthrax, and 2) that the
antibody response in animals correlates to a similar protective
response in humans.
---------------------------------------------------------------------------
\268\ Protective antigen [PA] is one of three proteins involved in
the mechanism of anthrax toxicity.
---------------------------------------------------------------------------
The lack of an immunological correlate of protection
against anthrax limits the extent of efficacy claims that can
be made about the current vaccine, and it poses a profound
challenge to the studies needed to approve an improved vaccine
or a shorter AVA shot course. In describing the challenges to
demonstration of efficacy for proposed changes in the dose and
use of the current anthrax vaccine, DOD noted:
Presently there are no precise serological or other
immunological correlates of protection to enable
conclusions to be drawn from immunization studies in
man. The extrapolation from animal studies to humans
likewise is seriously complicated by this fact. . . .
The demonstration in some animal models that protection
with the present vaccine varies across challenge
strains further complicates studies and limits the
breadth of efficacy claims that can be made.
To date, no animal or other potency test has been
demonstrated to be well correlated with protection of
humans. The potency test required for the present
vaccine \269\ has not been well correlated to efficacy
in humans and it is doubtful that it can be. (Emphasis
added).
---------------------------------------------------------------------------
\269\ The current potency test uses guinea pigs.
---------------------------------------------------------------------------
It has recently been stated that the antigenic
components of the licensed vaccine are not well defined
and that there is lot to lot variation in the level of
protective antigen. Because of these points, efficacy
studies will likely have to include multiple lots to
demonstrate consistency of protection.\270\
---------------------------------------------------------------------------
\270\ See supra note 138, p. 45 (presentation slide entitled,
``Challenges to Demonstration of Efficacy for the Proposed Changes in
Dose and Use of Anthrax Vaccine,'' included in supporting documentation
to MBPI IND application) (in subcommittee files).
Regarding efficacy, one author of an anthrax vaccine study
wrote, ``My concern is not the long-term health effects of this
vaccine, but rather that it is not efficacious against all
strains of B. anthracis. If I were the scientific director of
an offensive BW program for a government hostile to the U.S., I
would direct my investigators to repeat this experiment,
screening a larger number of B. anthracis isolates until a
strain was isolated that would kill immunized animals, and then
use that vaccine resistant strain as the stock for producing
spores to be used in filling BW submunitions.'' \271\
---------------------------------------------------------------------------
\271\ Memorandum from Gregory B. Knudson to Representative
Christopher Shays dated May 8, 1999, (in subcommittee files).
---------------------------------------------------------------------------
Genetically engineered anthrax strains could also defeat
the current vaccine if the resulting organism caused disease in
new ways. Reports that Russian scientists successfully inserted
genes into a virulent anthrax strain were received by DOD with
some skepticism. Col. Gerald Parker, then-commander of
USAMRIID, was quoted as saying the claims needed to be
evaluated ``to learn whether the advance is theoretical or
practical, and whether it could sidestep the American anthrax
vaccine.'' \272\ Taking a more skeptical approach to threat
assessment than DOD uses with regard to natural anthrax, Col.
Parker added, ``It's one thing to do this in the lab. But its a
whole different thing to produce it in large quantities to be
used as a weapon. That would be very difficult.'' \273\
---------------------------------------------------------------------------
\272\ William J. Broad, ``Gene-Engineered Anthrax: Is It a
Weapon?'' New York Times, Feb. 14, 1998 (in subcommittee files).
\273\ Ibid.
---------------------------------------------------------------------------
Concerns about the efficacy, and by implication the
necessity, of the vaccine are legitimate given the extent of
unproven, unknown, and perhaps unknowable, aspects of the
protection afforded. The vaccine almost certainly could be
overwhelmed by a high-dose aerosol exposure. Immunized troops
near an initial release point could still suffer significant
casualties. The vaccine may have diminished effect against
highly virulent strains, or combinations of strains. The
vaccine may provide no protection against genetically
engineered anthrax.
Recommendations
1. The force-wide, mandatory AVIP should be suspended until DOD obtains
approval for use of an improved vaccine
The anthrax vaccine program is not sustainable in its
present form. Due to the lack of assured production, AVIP phase
II has already been delayed. Confidence in the quality of the
vaccine stockpile is low and the capacity to procure sufficient
new production remains highly doubtful. The program should be
suspended while contingency plans for allocation of available
vaccine are formalized and research is conducted to obtain a
safer, more effective vaccine.
Signaling an awareness the anthrax immunization effort was
on weak conceptual and logistical footing from the start,
Secretary Cohen announced four preconditions to the start of
the program: supplemental vaccine testing, an adequate tracking
system, completed implementation and communication plans and an
independent scientific review. Those were appropriate. Had they
been more scrupulously addressed, the AVIP might be a very
different, much better program.
The military anthrax immunization program should have been
conditioned on completion of the same level of research and
testing required of other battlefield systems. We would not ask
U.S. forces to fight using rifles designed in the 1950's. We
should not ask them to rely on 1950's era medical technology,
when modern science has the capacity to produce an improved
vaccine. Much has changed in the biologics industry since the
AVA was first approved in 1970. As evidenced by FDA
inspectional findings in 1998 and 1999, not enough has changed
at the vaccine production facility to bring it into full
compliance with modern manufacturing standards. It is doubtful
the AVA would be approved by the FDA today.
As additional assurance the anthrax immunization program is
as safe as possible, DOD should test the vaccine for toxicity,
mutagenicity, carcinogenicity and reproductive effects in
animals. The current AVIP should be suspended while those
studies, and other steps recommended by the subcommittee, are
undertaken.
The AVIP should be suspended because it lacks an essential
element in a medical program: trust. However well-intentioned,
the anthrax vaccine effort is viewed by many with suspicion. It
is seen as another chapter in a long, unhappy history of
military medical malfeasance in which the healing arts are
corrupted to serve a lethal purpose.
The fundamental rationale for the AVIP--that something,
even an old, questionably effective vaccine, is better than
nothing--gives little comfort to those who daily see their
forebears and colleagues grow sicker from radiation testing,
Agent Orange, and Gulf war illnesses. If the noble experiment
fails, if the vaccine ultimately causes more casualties than
weaponized anthrax, many men and women in uniform do not
believe their Government will acknowledge their sacrifice or
treat their wounds.
Trust must be earned. It can be earned only with a degree
of candor and openness that has not been the hallmark of the
AVIP to date. While claiming a new awareness of the need for
effective risk communication, the Pentagon still reverts to
absolutist declarations, heavy handed propaganda, and ad
hominem attacks whenever the risks of the anthrax vaccine are
communicated too effectively or persistently. In a culture
based on a chain of command and the power to compel, attempts
at persuasion and education often devolve into intimidation.
Labeling opponents ``paranoics'' \274\ and ridiculing the
intelligence or courage of those with legitimate questions
\275\ are not the methods of modern risk communication.
---------------------------------------------------------------------------
\274\ See supra note 79.
\275\ See supra note 80.
---------------------------------------------------------------------------
Nowhere is DOD's failure to communicate the relative risks
and benefits of the AVIP more obvious than in reserve component
units. The bulk of vocal resistance to the AVIP has arisen in
the few Reserve and National Guard units included in phase I.
Those service members have more options than active duty
personnel. If they conclude the anthrax vaccine poses more risk
than benefit to their civilian and military careers, they can
resign, or seek a transfer to a non-mobility position. Many
have done so.
DOD appears to be in denial on this issue, ignoring clear
signs the anthrax program is having, and will certainly have, a
substantial impact on retention and morale in reserve component
units. At the subcommittee's September 29, 1999 hearing on the
subject, Maj. Gen. Paul Weaver, Director, Air National Guard,
testified there had been ``one known refusal documented.''
\276\ Previously, the subcommittee had received testimony and
correspondence from several members of Air Guard units who had
refused the vaccine, more than one of whom were in the hearing
room when Gen. Weaver made that statement.
---------------------------------------------------------------------------
\276\ Testimony of MG Paul Weaver, Director, Air National Guard,
NSVAIR anthrax hearing (V), p. 119.
---------------------------------------------------------------------------
Principal Deputy Assistant Secretary of Defense (Reserve
Affairs) Charles Cragin testified the impact of the AVIP on
retention was ``negligible'' \277\ despite having been given
information just days before that more than half the air crew
in one unit has submitted resignations attributable directly to
the anthrax program.\278\ At the same hearing, Mr. Cragin
conceded ``the Department's efforts to inform and educate
reserve personnel about the anthrax protection program were not
initially as robust as they should have been.'' \279\
---------------------------------------------------------------------------
\277\ Prepared statement of Charles Cragin, Acting Assitant
Secretary for Reserve Affairs, NSVAIR anthrax hearing (IV), p. 3.
\278\ Letter (with attachments) from Charles Cragin to
Representative Christopher Shays, attachment p. 1, Oct. 21, 1999. (in
subcommittee files).
\279\ Prepared statement of Charles Cragin, Acting Assitant
Secretary for Reserve Affairs, NSVAIR anthrax hearing (IV), p. 4.
---------------------------------------------------------------------------
Until much more is known about the true impact of a
mandatory vaccine program on retention, readiness, and morale
in the most voluntary sector of the all-volunteer U.S. armed
forces, the AVIP should be suspended.
Rather than risk long term health impairment, some service
members would be willing to consider the vaccine-preventable
risk of anthrax among the inherent, unavoidable risks of
military service. They do not have that option, an opportunity
to assume risk made available to essential civilian employees
of the Defense Threat Reduction Agency.\280\
---------------------------------------------------------------------------
\280\ See supra note 134.
---------------------------------------------------------------------------
Others view this force protection effort as an untested
medical solution to a purely mechanical problem--contamination
prevention and avoidance--better solved by physical rather than
pharmacological technology. With regard to the anthrax vaccine,
DOD appears to accept more unknowns and greater technological
risks than would be tolerated in any combat weapon system. As a
result, some service members are not convinced this
``commander's program'' is for their long-term protection as
much as for battlefield convenience and the preservation of
short-term mission capability while under anthrax attack.
Suspension of the AVIP would allow DOD to focus more attention
and resources on development and deployment of chemical defense
doctrine, tactics, detection capability as well as individual
and collective protection equipment effective against all
threats.
The subcommittee makes no recommendations regarding the
status of those service members who left the armed forces
voluntarily, or as the result of disciplinary actions, due to
the anthrax vaccine program. Just as each service branch,
operating under the Uniform Code of Military Justice,
determined its own approach to vaccine refusals, each should
determine through its own processes what appeals, if any, might
be available in the event the AVIP is restructured or
suspended.
2. DOD should accelerate research and testing on a second-generation,
recombinant anthrax vaccine
Despite the ``clear and present danger'' \281\ posed to
U.S. troops by anthrax as a biological weapon, DOD considers
development of an improved anthrax vaccine ``an unfunded
requirement.'' \282\ Had that requirement been addressed more
aggressively after the Persian Gulf war, the 8 to 10 year
development, testing and FDA approval process now posited by
DOD as an potential barrier to a new vaccine could have already
been breached.
---------------------------------------------------------------------------
\281\ See supra note 66, p. 1.
\282\ Testimony of Kwai-Cheung Chan, Director, Special Studies and
Evaluation Section, National Security and International Affairs
Division, GAO, NSVAIR anthrax hearing (IV), p. 100.
---------------------------------------------------------------------------
Although an improved vaccine based on recombinant
technology may not necessarily have better safety
characteristics than the current vaccine,\283\ it would address
two other problems plaguing the AVIP. Production of a second
vaccine, at a second site, would diversify the industrial
capacity to support so critical a program, making vaccine
supplies more abundant and more secure from attack. And,
because recombinant techniques do not require extensive
dedicated facilities, capital costs can be allocated across
more than one product, increasing the likelihood other
manufacturers would compete for DOD contracts.
---------------------------------------------------------------------------
\283\ Testimony of Col. Renata Engler, Chief, Allergy and
Immunology Department, Walter Reed Army Medical Center, NSVAIR anthrax
hearing (IV), p. 155.
---------------------------------------------------------------------------
The second generation vaccine studied by DOD was also more
consistently characterized in terms of PA content than the
AVA.\284\ Lot-to-lot consistency would address one challenge
noted by DOD to demonstrating efficacy of a vaccine that cannot
be tested in humans.\285\ It would also give commanders greater
confidence that vaccinated troops, to the greatest extent
possible, have achieved a more uniform level of protection.
---------------------------------------------------------------------------
\284\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Relations Division, GAO, NSVAIR anthrax hearing (IV), p. 13.
\285\ See supra note 108.
---------------------------------------------------------------------------
David Oliver, Principal Deputy Under Secretary of Defense
for Acquisition and Technology, said in testimony that DOD
would be reviewing procurement options with regard to a second
AVA production site versus a new vaccine. He suggested,
however, that funds spent on an improved anthrax vaccine would
limit funds available to address other bio-threats.\286\ That
trade-off puts anthrax on a par with other biological agents in
terms of threat, when in fact DOD considers anthrax the pre-
eminent bio-threat. Budgets estimates for the Joint Vaccine
Acquisition Program [JVAP] indicate DOD anticipates procurement
of limited, deployment-contingent stocks of vaccines against
other biological weapons, making anthrax the only agent
targeted for universal immunization. Improving the medical
prophylaxis against the primary threat should be a DOD funding
priority.
---------------------------------------------------------------------------
\286\ Testimony of David R. Oliver, Jr., NSVAIR anthrax hearing
(III), pp. 68-69.
---------------------------------------------------------------------------
DOD concedes, ``In the case of anthrax vaccine, the current
FDA-licensed vaccine is not ideal. The vaccine was developed in
the 1950's and 1960's by the state-of-the-art procedures at
that time, and licensed in 1970. Advances in biotechnology and
genetic engineering may enable improvements in the vaccine that
allow fewer doses or use of highly purified protective antigen.
The DOD scientists are pursuing both of these objectives. A
highly-purified recombinant protective antigen vaccine has
shown efficacy in animal models.'' \287\
---------------------------------------------------------------------------
\287\ Department of Defense, ``Information About the Anthrax
Vaccine and the Anthrax Vaccine Immunization Program,'' prepared by the
AVIP Agency, Jan. 25, 2000, pp. 12-13 (available at: http://
www.anthrax.osd.mil) (in subcommittee files).
---------------------------------------------------------------------------
But DOD is unwilling to wait for the research, development,
and FDA approval processes,\288\ even though DOD believes
``within a year we will get FDA approval for reduced dose based
on the science.'' \289\
---------------------------------------------------------------------------
\288\ Ibid.
\289\ Testimony of Col. Fred Gerber, Director, Health Care
Operations, Office of the Army Surgeon General, NSVAIR anthrax hearing
(V), p. 153.
---------------------------------------------------------------------------
To address the domestic bioterrorism threat, the Department
of Health and Human Services' National Institute of Allergy and
Infectious Diseases formed a working group to develop and test
a second generation anthrax vaccine, and the Institute has
funded some research. DOD should support those efforts.
With regard to an improved anthrax vaccine, the American
Public Health Association adopted a policy statement in
November 1999 urging DOD to ``delay any further immunization
against anthrax using the current vaccine or at least to make
immunization voluntary'' \290\ and to convene a commission of
military and non-military public health experts to review
safety and efficacy evidence for the current vaccine, attempt
to determine when an improved vaccine might be available, and
make recommendations about continuation of the current
program.\291\ Their recommendations were based on the concern
``that mandatory immunization with a vaccine of unproved
efficacy when an improved vaccine may soon be available, is
contrary to public health principles and may adversely effect
the acceptance of voluntary or mandatory immunization programs
in which there is good evidence of efficacy and safety. . . .''
\292\
---------------------------------------------------------------------------
\290\ ``Anthrax Immunization,'' American Public Health Association,
policy statement No. 9930, Nov. 10, 1999.
\291\ Ibid.
\292\ Ibid.
---------------------------------------------------------------------------
3. DOD should pursue testing of the safety and efficacy of a shorter
anthrax inoculation regimen
A shorter shot course could reduce the cost of the
immunization program, simplify delivery logistics, and lower
the incidence of adverse reactions.
According to GAO testimony, ``No studies have been done to
determine the optimum number of doses of the anthrax vaccine.''
\293\ The original inoculation schedule of three doses was
based on a regimen developed using animals in the early 1950's.
However, three people who received three doses of a weaker
formulation of the vaccine became infected after exposure to
anthrax. The number of doses was then arbitrarily increased to
six, the number used in the only human efficacy study published
in 1962, and thus the number approved by FDA.\294\
---------------------------------------------------------------------------
\293\ Testimony of Kwai-Cheung Chan, Director, Special Studies and
Evaluation Section, National Security and International Affairs
Division, GAO, NSVAIR anthrax hearing (IV), p. 97.
\294\ Prepared statement of Kwai-Cheung Chan, Director, Special
Studies and Evaluation Section, National Security and International
Affairs Division, GAO, NSVAIR anthrax hearing (IV), p. 5.
---------------------------------------------------------------------------
Even if a prolonged, multi-shot regimen is necessary to
generate an initial immune response, the annual booster may be
unnecessary. GAO noted:
In November 1971, the Division of Biologics Standards,
NIH, noted an apparent increase in reports of adverse
reactions after individuals received booster shots. The
Division considered it advisable to reevaluate the need
for annual boosters and possibly the amount of the
booster dose. Although the record is unclear as to
whether or not NIH requested a reevaluation, to date,
no such reevaluation has been done.\295\
---------------------------------------------------------------------------
\295\ Ibid., p. 6.
The 1993 DOD Directive on biological warfare defense
mandates immunization ``against validated biological warfare
threat agents, for which suitable vaccines are available, in
sufficient time to develop immunity before deployment to high
threat areas. . . .'' \296\ (Emphasis added). For this purpose,
``suitable'' should not just mean FDA approved, but
demonstrably as safe and effective as possible for the intended
military use. A vaccine that takes 18 months, and annual
boosters, to confer immunity should not be considered suitable
under the policy.
---------------------------------------------------------------------------
\296\ See supra note 7.
---------------------------------------------------------------------------
In 1995, the Joint Program Manager for Biological Defense
reported, ``The immunization schedule of 6 shots over 18 months
has stopped the approval process for an annual immunization
program against this high threat biological warfare agent.
Moreover, it has been used by critics to question the relevance
of the biological defense [BD] vaccine program to the DOD.''
\297\
---------------------------------------------------------------------------
\297\ Col. John C. Doesburg, Joint Program Manager for Biological
Defense, memorandum on ``Urgent Requirement for Integrated Command
Support to Revise the Immunization Schedule for Anthrax Vaccine'' (JPO
0045) from the Department of the Army, Nov. 17, 1995 (in subcommittee
files).
---------------------------------------------------------------------------
If the time to develop immunity could be reduced
substantially, use of the anthrax vaccine would be safer and
could be targeted far more effectively to forces deploying to
high threat areas.
Based on animal studies and research into the immunological
response to the vaccine in humans, DOD concludes most persons
acquire the bulk of whatever protection is achieved after two
or three shots.\298\ DOD documents assert that three
inoculations provide functional protection, and the services'
AVIP implementation plans set as ``desirable'' the goal that
``all personnel assigned to high threat areas receive their
first three shots prior to deployment.'' \299\ In the interest
of reducing adverse reactions, particularly in persons whose
immune systems have already mounted a complete response to the
vaccine, DOD should put its belief in the efficacy of a reduced
shot course to the test of rigorous scientific trials.
---------------------------------------------------------------------------
\298\ Testimony of Maj. Gen. Robert Claypool, Deputy Assistant
Secretary for Health Operations Policy, NSVAIR anthrax hearing (IV), p.
179; Arthur M. Friedlander, Philip R. Pittman, and Gerald W. Parker,
``Anthrax Vaccine: Evidence for Safety and Efficacy Against
Inhalational Anthrax,'' the Journal of the American Medical
Association, Dec. 8, 1999, vol. 282, No. 22, pp. 2104-2106.
\299\ See supra note 46, p. 1, sec. 1(a)(8).
---------------------------------------------------------------------------
To the extent those efficacy studies were put aside due to
the lack of a correlates of human immunity, that challenge will
have to be overcome in any event as DOD attempts to develop and
deploy other vaccines against other bio-threats. That work
might as well be done in support of a safer vaccine against the
primary biological warfare threat, anthrax.
In terms of increased safety, there is also some evidence
an intramuscular injection would produce fewer side effects and
adverse reactions than subcutaneous administration. DOD
expended significant time and resources in 1994 and 1995 on
plans and programs to demonstrate the safety and efficacy of a
shorter anthrax inoculation regime, and a different route of
administration, but appears to have all but abandoned those
efforts when planning for the AVIP began. Support for the FDA
application to reduce the shot course seems to have been
redirected to vaccine acquisition and AVIP logistics.
4. DOD should enroll all anthrax vaccine recipients in a comprehensive
clinical evaluation and treatment program for long term study
DOD only recently began ``to design a set of studies to
better evaluate the long term safety of the anthrax vaccine . .
. to conform with present-day, post-marketing practices.''
\300\ While employing active surveillance techniques, these
will be cohort studies because ``[i]t would be labor-intensive,
cost-prohibitive, and would not conform to civilian
expectations for us to use this in all 2.4 million service
personnel whom we will administer the vaccine to.'' \301\
According to Gen. Claypool, DOD will also use linked databases
to conduct active surveillance of vaccine recipients, using
DEERS and ``the large medical database residing at a tri-
service defense medical surveillance system here in the
National Capital region of the Walter Reed installation.''
\302\
---------------------------------------------------------------------------
\300\ Testimony of Maj. Gen. Robert Claypool, Deputy Assistant
Secretary for Health Operations Policy, NSVAIR anthrax hearing (IV), p.
108.
\301\ Ibid.
\302\ Ibid., p. 109.
---------------------------------------------------------------------------
But these steps, coming more than 1 year after AVIP
implementation, are not enough to monitor the impact of the
vaccine program on military health. Having missed the
opportunity to study the large cohort of service members who
received the AVA during Operations Desert Shield and Desert
Storm, DOD has an obligation to reach beyond ``civilian
expectations'' to evaluate the safety of this vaccine.
Particularly for members of reserve component units, access
to primary care and specialists at military facilities can be
limited. According to DOD, adverse events after the anthrax
vaccine are ``line of duty illnesses.'' \303\ Therefore,
---------------------------------------------------------------------------
\303\ Dr. Sue Bailey, ``What Everyone Needs to Know about the
Anthrax Vaccine'' quarterfold brochure, Department of Defense, Nov. 1,
1999, p. 3 (in subcommittee files).
a member of the Reserve Component may present
themselves for initial treatment and evaluation at any
military treatment facility, after vaccination during a
period of duty. The member will be examined and
provided necessary medical care. Once treatment is
rendered or the individual's emergent condition is
stabilized, a Line of Duty and/or Notice of Eligibility
status will be determined by the member's unit, as
required. No treatment beyond that justified to
stabilize the condition or emergency is authorized
---------------------------------------------------------------------------
until Service connection is validated.
But requiring an immediate determination of service-connection
for vaccine related health effects means many short term, and
most long term, adverse reactions will not be monitored by DOD
physicians. The causal attribution of health effects to
inoculations is difficult, becomes more difficult over time,
and remains unlikely in a military program institutionally
resistant to any suggestion the vaccine is not safe. Service
members should not bear the burden of proof the vaccine caused
their ill-health subsequent to inoculation. The process of
proving service-connection has frustrated Gulf war veterans'
efforts to obtain accurate diagnoses, effective treatments, and
fair compensation for their unexplained illnesses. It should
not be repeated in the AVIP.
Enrollment of every vaccine recipient in a clinical
evaluation and treatment protocol would allow DOD to capture a
unique and valuable data set for use in their longitudinal
studies, avoiding disputes over cohort selection bias and other
methodological issues. The evaluation and treatment program
could also be the vehicle for assembly of the multidisciplinary
teams envisioned by Dr. Engler \304\ to develop and implement
clinical protocols and maintain a consistent standard of care
in the AVIP. It would also help assure service members the
vaccine program, as a medical force protection effort, has as
its primary purpose the protection of the health of the force.
---------------------------------------------------------------------------
\304\ E-mails from Col. Renata Engler dated Dec. 4-8, 1998 (in
subcommittee files).
---------------------------------------------------------------------------
5. While an improved vaccine is being developed, use of the current
anthrax vaccine for force protection against biological warfare
should be considered experimental and undertaken only pursuant
to FDA regulations governing investigational testing for a new
indication
Under FDA regulations, use of an FDA-approved product in an
unapproved way, or for an unapproved purpose, can only be
undertaken pursuant to clinical trial protocols contained in
Investigational New Drug [IND] applications.\305\ IND protocols
must be approved by an Institutional Review Board charged to
monitor the scientific credibility and ethical soundness (i.e.,
patient protections) of the trial. FDA must agree the trial
proves the product is safe and effective for the proposed use.
Informed consent must be obtained from persons enrolled in IND
drug or vaccine trials.
---------------------------------------------------------------------------
\305\ 21 CFR Part 312.
---------------------------------------------------------------------------
If DOD proposed to use the anthrax vaccine against a
disease or indication not currently described in the FDA-
approved product labeling (i.e., high blood pressure), an IND
application would be required. If DOD proposed to alter the
FDA-approved AVA inoculation regimen (i.e., by eliminating one
or more of the six shots), and IND would be required.
Despite the fact the vaccine was approved as safe and
subsequently deemed effective only against cutaneous anthrax
infection, DOD asserts use of the FDA-approved AVA as
prophylaxis against weaponized, inhalation anthrax does not
constitute an off-label use against a new indication because
``[w]hile the package insert for this vaccine is nonspecific as
to the route of exposure, DOD has long interpreted the scope of
the license to include inhalation exposure, including that
which would occur in a biological warfare context.'' \306\
---------------------------------------------------------------------------
\306\ Letter from Dr. Stephen C. Joseph to Dr. Michael A. Friedman
dated Mar. 4, 1997 (in subcommittee files).
---------------------------------------------------------------------------
While some in DOD may have interpreted the scope of MBPI's
FDA license to include inhalation anthrax by implication,
others proceeded as if explicit labeling for the indication
would be necessary. Throughout development of the anthrax
policy that eventually became the AVIP, some in DOD interpreted
FDA regulations as requiring approval of both a reduced number
of inoculations and the new indication. A 1995 memo states:
The use of a reduced schedule to protect service
members from aerosol exposure to anthrax can only
legally be done if the FDA licenses the vaccine for
that specific schedule and indication. . . . Obtaining
FDA license approval for a specific immunization
schedule change and for a labeled indication change
(aerosol challenge) must provide data that establish
safety of two doses of the vaccine given at 0 to 4
weeks since this schedule does not mimic the current
schedule of 0, 2 and 4 weeks. More extensive problems
exist in demonstrating vaccine efficacy against an
aerosol challenge.\307\
---------------------------------------------------------------------------
\307\ Micheal J. Gilbreath, Ph.D., ``Is the current Anthrax
vaccination regimen necessary?'' Department of Defense information
paper (JPO 0044), Nov. 10, 1995, pp. 1-2.
In September 1996, the vaccine manufacturer, MBPI,
submitted an IND application which said, ``The ultimate purpose
of this IND is to obtain a specific indication for inhalation
anthrax and a reduced vaccination schedule.'' \308\ (Emphasis
added). Briefing slides produced by USAMRIID in October 1997
reference two separate objectives to be met in a supplement to
the AVA license:
---------------------------------------------------------------------------
\308\ See supra note 138, p. 1.
---------------------------------------------------------------------------
Supplement to AVA license to reduce the number
of immunizations and change the route of immunization.
Supplement AVA license to explicitly include
inhalational anthrax as an indication.\309\
---------------------------------------------------------------------------
\309\ Department of Defense, ``Supplemental to AVA License''
USAMRIID presentation slides, Oct. 28, 1997 (in subcommittee files).
---------------------------------------------------------------------------
Since 1997, the Department of Defense Nuclear/Biological/
Chemical [NBC] Defense--Annual Report to Congress has referred
to medical CBW countermeasures proven safe because they have
``been widely used to treat other medical conditions.'' \310\
The report cites pyridostigmine bromide, the botulinum toxoid
vaccine, both used for CB prophylaxis only pursuant to INDs,
and the anthrax vaccine. But DOD's interpretation of the
current AVA labeling rests on the conclusion there is but one
indication--anthrax infection acquired by any means. Against
what ``other medical condition'' was the anthrax vaccine used
to prove its safety?
---------------------------------------------------------------------------
\310\ Department of Defense Nuclear/Biological/Chemical [NBC]
Defense--Annual Report to Congress, March 1999, pp. 3-3 to 3-4;
Department of Defense Nuclear/Biological/Chemical [NBC] Defense--Annual
Report to Congress, February 1998, pp. 3-4 to 3-5; Department of
Defense Nuclear/Biological/Chemical [NBC] Defense--Annual Report to
Congress, March 1997, pp. 3-4 to 3-5.
---------------------------------------------------------------------------
When DOD asked the FDA to concur with the implicit
inclusion of inhalation anthrax in the current product
labeling, the response was affirmative but tepid. FDA Lead
Deputy Commissioner Michael Friedman wrote:
While there is a paucity of data regarding the
effectiveness of Anthrax Vaccine for prevention of
inhalation anthrax, the current package insert does not
preclude this use. The original efficacy trail clearly
showed that the vaccine conferred a high level of
protection against cutaneous exposure. None of the 5
inhalation cases in this trial occurred in Anthrax
Vaccine recipients, but these data alone are
insufficient to allow definitive statistical
conclusions. Results from animal challenge studies have
also indicated that pre-exposure administration of
Anthrax Vaccine protects against inhalation anthrax.
Therefore, I believe your interpretation is not
inconsistent with the current label.\311\
---------------------------------------------------------------------------
\311\ Letter from Dr. Michael A. Friedman to Dr. Stephen C. Joseph
dated Mar. 13, 1997 (in subcommittee files).
It was on this basis DOD proceeded to design the AVIP
without informed consent procedures, or an informed consent
waiver, and without other elements of a clinical trial such as
consistent data gathering and detailed health outcome
monitoring.
DOD was aware of the extensive problems confronting the
effort to prove vaccine efficacy for the new indication, most
notably that ``. . . no animal or other potency tests has [sic]
been demonstrated to be well correlated with protection of
humans.'' \312\ DOD conducted, and plans to continue, studies
attempting to validate an animal model so findings can be
extrapolated to humans.
---------------------------------------------------------------------------
\312\ See supra note 307, p. 2. The memo continues, ``The potency
test required for the present vaccine has not been well correlated to
efficacy in humans.'' The current potency test uses guinea pigs. Tests
challenging different animal species with a range of anthrax strains
showed the vaccine provides varied levels of protection. Against some
strains, vaccinated guinea pigs and mice suffered 100 mortality. In DOD
studies using nonhuman primates (rhesus monkeys) between 88 and 100
percent of the vaccinated animals survived.
---------------------------------------------------------------------------
In launching the AVIP, DOD did not confront those problems
but sidestepped them by concluding use of the vaccine to
prevent anthrax infection, however acquired, would not require
an IND as long as the approved inoculation schedule was
followed. So the AVIP's cumbersome logistics, additional costs,
and increased risk of adverse reactions all flow directly from
an unwillingness to do the research and testing to develop a
better vaccine or improve the safety and efficacy of the
current AVA.
That research and testing will have to be done in any
event. In 1997 DOD told Congress:
DOD complies with all Food, Drug and Cosmetic Act
requirements. The Food and Drug Administration [FDA]
requires large-scale field trials in human subjects to
demonstrate efficacy of drug and biologicals prior to
licensure. There are, however, legal and ethical
constraints that preclude such efficacy studies for NBC
countermeasures. Field studies of efficacy cannot be
performed, since exposure to most NBC agents does not
usually occur naturally. Moreover, the high lethality
and/or toxicity of NBC agents also makes it unethical
to expose human subjects in controlled efficacy studies
usually required by the FDA for product licensure
(e.g., test of effectiveness of the product against the
threat in humans). For these reasons, many NBC
countermeasures are likely to remain in an
Investigational New Drug [IND] status, requiring their
administration under provisions of an approved protocol
and with written informed consent from their service
members. In contingency situations, DOD may request a
waiver of informed consent from the FDA. DOD continues
to work with the FDA to seek alternative methods for
demonstrating safety and efficacy of NBC medical
countermeasures and to obtain their licensure.\313\
(emphasis added)
---------------------------------------------------------------------------
\313\ See supra, note 310, 1998 report, p. 3-4.
Given the predicted likelihood NBC vaccines will be
available only in IND status for some years to come, DOD will
need to develop the capacity to conduct broad-based clinical
trials and effectively communicate risk/benefit assessments
through informed consent processes. In the interests of
deploying a safer, presumably more effective vaccine against
the pre-eminent biological warfare threat, DOD should be
willing to develop that capacity now. Instead, DOD has chosen
to address the primary threat with a dated, secondary
countermeasure with substantial unknowns regarding quality,
safety, and efficacy.
In prescribing the vaccine, DOD is engaging in the practice
of medicine. ``It is true doctors can use drugs off label. It
is never true they can do so without informed consent of the
patient . . . You are not immunized from getting informed
consent.'' \314\ If DOD were to concede administration of AVA
against inhalational battlefield exposure is an off label use,
informed consent would be required. The AVIP could be
transformed, for most, into a voluntary program, with limited
mandatory usage of the vaccine possible only pursuant to a
carefully monitored informed consent waiver.
---------------------------------------------------------------------------
\314\ Testimony of Arthur Caplan, Ph.D., Force Protection:
Improving Safeguards for Administration of Investigational New Drugs to
Members of the Armed Forces, 106th Cong., 1st sess. (1999), unofficial
transcript, p. 77 (subcommittee on National Security, Veterans Affairs
and International Relations hearing of Nov. 9, 1999) (in subcommittee
files).
---------------------------------------------------------------------------
In a statement submitted to the subcommittee, the
Association of American Physicians and Surgeons asserted:
A distinction must be made between treatment and
experimentation. It may be asserted that anthrax
vaccine (unlike pyridostigmine bromide as used in the
Gulf War or anti-botulinum vaccine) constitutes
``treatment,'' or that it is not experimental because
of being declared safe and effective by FDA. . . . In
fact, the anthrax vaccine was licensed by the FDA
before efficacy studies were required. Its efficacy
against inhalational anthrax has been questioned. . . .
British epidemiologist suggested that troops be
publicly randomized to receive active vaccine or
placebo, clearly implying that many consider the
vaccine to be experimental.\315\
---------------------------------------------------------------------------
\315\ Submitted statement of Dr. Jane M Orient, executive director,
Association of American Physicians and Surgeons, NSVAIR anthrax hearing
(I), p. 119, citing the European Journal of Epidemiology 4:12-19, 1998
and Ness AR, Harvey I, Gunnell D, Smigh GD: ``All troops sent to Gulf
should be randomized to receive anthrax vaccination or placebo.''
British Medical Journal 316:1322, 1998.
The AAPS recommended a careful examination of the medical
ethics involved in military, and civilian, vaccination efforts,
noting the entire point of informed consent in combat is ``not
to prevent soldiers from obtaining whatever protection may be
afforded them by an investigational agent that has not been
adequately tested, but rather, it is to give them the choice of
whether they think the `protection is worth the risks of
adverse effects.' '' \316\
---------------------------------------------------------------------------
\316\ Ibid. (quoting Grodin MA, Annas GJ: Journal of the American
Medical Association 277:712-713, 1997).
---------------------------------------------------------------------------
Although DOD's track record administering INDs or informed
consent waivers is not exemplary,\317\ current procedural
safeguards, adopted since the Gulf war, provide far more
protection to service members receiving investigational
products than the AVIP now provides.
---------------------------------------------------------------------------
\317\ In 1990, DOD requested authority to administer IND products,
pyridostigmine bromide and botulinum toxoid vaccine, to certain
military personnel. DOD also requested a waiver of informed consent
requirements in connection with the use of those products by the armed
forces. The FDA granted the DOD requests under the terms of an interim
rule establishing the procedures and conditions under which informed
consent waivers could be obtained by DOD. But DOD did not meet the
conditions FDA placed on the waivers, failing to provide information to
individual service members about the IND products and failing to keep
the medical records necessary to fulfill the protocols and capture data
about the safety of the drugs. Despite some improvements in medical
recordkeeping, DOD's next use of an IND vaccine showed similar
problems. In 1997, the General Accounting Office observed ``nearly one
fourth of the soldiers who received an investigational tick-borne
encephalitis vaccine before deploying to Bosnia did not have this
information noted in their files.'' (``Defense Health Care: Medical
Surveillance Improved Since Gulf War, but Mixed Results in Bosnia,''
[GAO/NSIAD-97-136] U.S. General Accounting Office, May 13, 1997, p.
33.)
---------------------------------------------------------------------------
In November 1997 the subcommittee proposed, and the full
Government Reform and Oversight Committee approved, an
oversight report on Gulf war veterans' illnesses containing 18
findings and 18 recommendations.\318\ Among them was the
finding that ``[t]he FDA was passive in granting and failing to
enforce the conditions of a waiver to permit use of PB by DOD''
and the recommendation that ``FDA should grant a waiver of
informed consent requirements for the use of experimental or
investigational drugs by DOD only upon receipt of a
Presidential finding of efficacy and need.'' \319\
---------------------------------------------------------------------------
\318\ Gulf War Veterans' Illnesses: VA, DOD Continue to Resist
Strong Evidence Linking Toxic Causes to Chronic Health Effects, 2d
report by the Committee on Government Reform and Oversight, House
Report 105-388, Nov. 7, 1997, pp. 3-6.
\319\ Ibid.
---------------------------------------------------------------------------
Legislation reflecting that recommendation was introduced
in both chambers of Congress.\320\ The 1999 Defense
Authorization Act contained provisions, codified at 10 U.S.C.
1107(f), implementing the recommendation by strengthening
notice requirements and by requiring a Presidential
authorization for any waiver of informed consent.
---------------------------------------------------------------------------
\320\ H.R. 4035, 105th Cong., 2d sess.; S. 2057, 105th Cong., 2d
sess.
---------------------------------------------------------------------------
In view of the new statutory provision, FDA on October 5,
1999 revoked the 1990 interim final rule and issued a new
regulation to govern DOD compliance with IND conditions and
informed consent waivers.\321\
---------------------------------------------------------------------------
\321\ Federal Register, 21 CFR Parts 50 and 312, Oct. 5, 1999, p.
54180.
---------------------------------------------------------------------------
On September 30, 1999 the White House issued Executive
Order 13139 establishing the procedures by which the President
would comply with the new law.\322\ The Executive order says
``[w]aivers of informed consent will be granted only when
absolutely necessary'' and only upon a written determination by
the President that obtaining consent is not feasible, is
contrary to the best interest of the service member or is not
in the interest of national security. In the event a waiver is
granted, the DOD Secretary must notify Congress and publish a
notice in the Federal Register. No waiver may last more than
one year. Waivers may be renewed based on a new, fully
documented request.'' \323\
---------------------------------------------------------------------------
\322\ Executive order of Sept. 30, 1999, ``Improving Health
Protection of Military Personnel Participating in Particular Military
Operations'' No. 13139, the White House, Washington, DC.
\323\ Ibid.
---------------------------------------------------------------------------
The statute establishes clear U.S. policy that waiver of
informed consent in military operations is deemed appropriate
and necessary under certain circumstances. The statute, the FDA
interim rule and Executive Order 13139 describe, and limit,
those circumstances and attempt to ensure any decision to use
IND drugs or vaccines without informed consent is as open as
possible, supported by sufficient information and authorized at
the highest level.
The new regime for waiving informed consent requirements
appears far more rigorous and transparent than the system
employed under the original interim rule. The statute is very
explicit in describing the information that must be provided to
each individual service member being given an IND drug or
vaccine. The written information must include a clear statement
the substance is investigational, the reason the drug or
vaccine is considered necessary, information regarding possible
side effects and drug interactions, and any other information
FDA may require as part of the IND protocol.
That is more clinically useful information than the AVIP
now routinely conveys. Consistently providing balanced risk/
benefit assessments in an IND setting would also move DOD
closer to its stated goal of more effective risk communication.
According to an article linked to the DOD AVIP website:
People are different. One size does not fit all when
it comes to explaining risk. Some prefer short, simple
messages about a vaccine's benefits and risks.8,12,68
These people, presumably a majority of the population,
will be satisfied with the summary information
comprising the Vaccine Information Sheets [VISs]
published by the Centers for Disease Control and
Prevention. Others want more detailed information. Some
will scour the literature to explore every fact they
can find. The goal of risk communication involving
vaccines should be informed consent.68 True consent to
vaccination is only possible if the individual has
received all the information he or she wants and
understands that information. Then an informed vaccine
decision can be made. Providing this information
demonstrates respect for the individual. From the
clinician's perspective, the consent process can be
part of the efforts to identify contraindications to
vaccination (e.g., severe hypersensitivity,
immunodeficiency).\324\
---------------------------------------------------------------------------
\324\ Department of Defense, ``Anthrax Vaccine Immunization
Program'' at Internet page http://www.anthrax.osd.mil/ citing John D.
Grabenstein and James P. Wilson, ``Are Vaccines Safe? Risk
Communication Applied to Vaccination,'' Hospital Pharmacy, Vol. 34, No.
6, pp 713-729 (available at http://www.anthrax.osd.mil/SCANNED/
ARTICLES/grabedocs/vaccines.htm).
The FDA ``believes that exceptions from the informed
consent requirement should apply rarely and only when
sufficient additional protections are provided to the military
personnel affected.'' \325\ The agency also expresses the view
that DOD should pursue drug development through normal
regulatory procedures, despite the obvious difficulty of
acquiring efficacy data regarding chemical and biological
warfare exposures. In the future, requests for informed consent
waivers must be accompanied by a history and projected time
line for full scale development of the drug or vaccine in
question.\326\ No more waiting until the eve of war to shortcut
a process that could have been underway for months or years.
---------------------------------------------------------------------------
\325\ See supra note 321 p. 51484.
\326\ Ibid.
---------------------------------------------------------------------------
Under the new law, only the President may waive prior
consent requirements, and only after certifying in writing that
obtaining consent is not feasible, is contrary to the best
interest of the service member, or is not in the interest of
national security. With regard to the first two justifications,
the President must apply the standards and criteria used by the
FDA for waivers. Those standards and criteria are detailed in
the new FDA interim rule. To meet them, the Secretary of
Defense must document for the President all the scientific
data, threat assessment, lack of alternatives, and conditions
under which the IND product will be used.
The FDA regulation strengthens the role of the
Institutional Review Board [IRB] in approving and monitoring
the IND protocols for which waivers are granted. IRBs are
panels charged with assuring that clinical trials have
legitimate scientific goals and that protocols protect human
subjects. Under the regulation, an IRB must review all aspects
of the proposed IND and waiver. Significantly, the IRB must
include at least three members who are not employees of the
Federal Government. This should add some element of independent
review to DOD waiver requests. The rule also requires detailed
certifications from DOD regarding recordkeeping systems,
medical staff training, and communication of benefits and
risks.
The Executive order of September 30, 1999 mirrors the FDA
regulation in many respects, requiring the DOD Secretary to
support a waiver request with written justification, rationale,
and proof of IRB review. The Assistant to the President for
National Security Affairs and the Assistant to the President
for Science and Technology must also review the request. After
approval of a waiver, the Eexecutive order requires monitoring
and periodic reports on compliance with IND protocols and
waiver conditions.
These more explicit and elaborate procedures address many
of the problems noted in the execution of the Gulf war waivers.
If applied rigorously, those safeguards could also form the
basis for a mandatory anthrax vaccine program for certain
deployed forces, Special Forces, or other elements determined
by the President to warrant vaccination in the interests of
national security. The remainder of the force could choose to
enroll in an IND protocol \327\ or assume the risks of
biological warfare not addressed by individual and collective
protection, detection, battle tactics and deterrence.
---------------------------------------------------------------------------
\327\ Open protocols could be established for the on-going trial of
a reduced vaccine regimen or a trial of a purer vaccine.
---------------------------------------------------------------------------
In July 1999, the Air Force Times editorialized it was time
to ``Stop Mandatory Anthrax Inoculations'' because the
manufacturer appeared unreliable, and because:
More research is needed to understand the long-term
risk of using the anthrax vaccine. And now, long after
initiating the vaccination program, the Pentagon is
finally planning such a long-term study of the
vaccine's health effects. That's good, but until those
risks are understood, the Pentagon should proceed with
caution--not reckless abandon.\328\
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\328\ ``Stop Mandatory Anthrax Inoculations,'' Air Force Times,
Army Times Publishing Co., Jul. 12, 1999, p. 44.
The editorial concluded ``the risks of the vaccine are
outweighed by the risk of contracting anthrax'' \329\ and
advised service members to take the shots. ``But in the absence
of empirical evidence proving the vaccine's long-term safety,
the troops should be given the chance to decline. Give them the
information they need to make wise, informed decisions for
themselves. Let those who decline live with what they consider
a reasonable risk.'' \330\
---------------------------------------------------------------------------
\329\ Ibid.
\330\ Ibid.
DISSENTING VIEWS OF HON. HENRY A. WAXMAN, HON. ROD R. BLAGOJEVICH, HON.
TOM LANTOS, HON. MAJOR R. OWENS, HON. ELEANOR HOLMES NORTON, HON.
ELIJAH E. CUMMINGS, HON. DANNY K. DAVIS, HON. JOHN F. TIERNEY, HON.
HAROLD E. FORD, JR., AND HON. JANICE D. SCHAKOWSKY
We agree with many points set forth in the report. We
submit dissenting views, however, because we disagree with the
report's primary recommendations regarding whether to suspend
the Department of Defense [DOD] program and reclassify the
anthrax vaccine as ``experimental.''
i. assured production and capacity
We agree that the anthrax program is vulnerable to supply
shortages. Because the producer has been unable to obtain the
Food and Drug Administration [FDA] approval to reopen its
renovated production facility, no source of anthrax vaccine
currently exists. Without a guaranteed supply, DOD will
continue to experience difficulty meeting the demand it has
created through its program to vaccinate all 2.4 million
service members.
We also agree that the program is vulnerable to price
increases. Within a year of agreeing to produce anthrax vaccine
for DOD, the producer and DOD renegotiated the terms of the
contract. The producer obtained advance payments, a price
increase, and permission to sell on the open market, despite
DOD's need for the vaccine. Explanations about the
foreseeability and need for this renegotiation were
unsatisfactory.
Although we acknowledge that DOD enters into exclusive
contracts as a regular course of business, we agree that
accelerating research and testing on a second-generation,
recombinant anthrax vaccine may encourage competition and
enhance production stability. One potential benefit of such a
vaccine is that it could be produced in various facilities
rather than a single, dedicated facility. In addition to
enhancing competition, diversifying the source of anthrax
vaccine could reduce security risks at production sites.
ii. complexity of program
The anthrax vaccination program is logistically complex.
The FDA-licensed shot regimen requires six shots over a period
of 18 months and a booster shot annually thereafter. The report
correctly raises serious concerns about DOD's ability to
perform successfully this regimen for certain members of its
force. For example, it is difficult for DOD to deliver timely
shots to Reserve and Guard service members who report for duty
less frequently than active duty members.
We also agree that DOD's ``timeliness goal'' of vaccinating
90 percent of service members within 30 days after vaccinations
are due is insufficient. Under this standard, the first three
vaccine inoculations--which FDA requires in 2-week intervals--
instead could be delivered on the same day and still be
considered ``timely.'' We note that FDA wrote to DOD in
September 1999 expressing concern with potential deviations
from the approved schedule.\1\
---------------------------------------------------------------------------
\1\ Letter from Dr. Katherine C. Zoon to Dr. Sue Bailey (Sept. 29,
1999).
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If DOD continues the vaccination program, we recommend that
DOD take measures to improve the administration of its program.
We note that DOD has accomplished significant improvements,
such as the utilization of the Defense Enrollment Eligibility
Reporting System to combine service-based record systems into
one central repository. In addition to upgrading these
recordkeeping systems through the Composite Health Care System,
we recommend that DOD revise its timeliness standard from 1
month to a window of days.
iii. safety monitoring
We agree that vaccine safety could be monitored more
thoroughly and comprehensively. The report acknowledges that,
``[a]s with any vaccine, anthrax inoculation can cause adverse
health events in some individuals . . ..'' The report also
points out that, at the rates of adverse reactions cited by
DOD, implementation across the entire force could produce
thousands of systemic and local reactions. Although only a
small percentage of these would require extended treatment or
hospitalization, we agree that aggressively managing this
anticipated caseload must be a priority for DOD.
The report suggests that the program may not be capable of
performing adequate monitoring because of DOD's ``institutional
resistance to associating health effects with the vaccine.''
The subcommittee heard from several service members who relayed
accounts of inappropriate behavior by DOD personnel. Although
the subcommittee did not verify the prevalence or accuracy of
these accounts, we do not doubt that such actions inevitably
occur, whether or not officially sanctioned. While we disagree
that DOD is incapable of performing adequate safety monitoring,
we believe DOD should meet a higher standard. We recommend
several measures to raise DOD's performance.
As part of its safety monitoring program, DOD relies on the
Vaccine Adverse Event Reporting System [VAERS]. Under this
system, FDA collects reports of symptoms temporally related to
the receipt of the anthrax vaccine. DOD requires its physicians
to file VAERS reports only if such reactions result in
hospitalization or the loss of 24 hours of work. Although DOD
physicians are permitted to file VAERS reports in cases below
this threshold, it appears this is seldom done. We recommend
that DOD require its physicians to file VAERS reports for all
adverse events that result in hospitalization, any amount of
missed duty, or any other negative health effects considered
relevant by service members or their physicians.
The subcommittee also heard from several service members
who claimed they were never told about VAERS forms or were
unable to access them. DOD has been proactive in this regard
by, in addition to taking other steps, placing on its website a
direct link to the on-line FDA VAERS form. To augment this
effort, we suggest that DOD consider distributing paper copies
of VAERS forms with each dose of anthrax vaccine administered.
iv. vaccine safety
The report does not conclude that the anthrax vaccine is
unsafe. The report states that the vaccine ``may be as safe as
many other approved products'' and ``can be considered
nominally safe.'' In their appearances before the subcommittee
and committee, officials from the General Accounting Office
[GAO] never stated that they believed the vaccine is unsafe.
Instead, both the committee report and GAO argue that the
vaccine's safety has not been demonstrated sufficiently to
date.
FDA testified on several occasions before the subcommittee
and the full committee that the agency believes the vaccine is
safe. On April 29, 1999, FDA stated, ``[w]e believe anthrax
vaccine is a safe and effective vaccine for the prevention of
anthrax disease.'' \2\ At a later hearing, FDA officials
reported that ``FDA continues to view the anthrax vaccine as
safe and effective for individuals at high risk of exposure to
anthrax, when used in accordance with the approved labeling.''
\3\ At another hearing, FDA officials explained why they
believe the vaccine is safe:
---------------------------------------------------------------------------
\2\ Anthrax (II): Safety and Efficacy of the Mandatory Vaccine,
Hearing before the Subcommittee on National Security, Veterans Affairs,
and International Relations, House Committee on Government Reform,
106th Cong., 1st sess. (Apr. 29, 1999) (testimony of Dr. Katherine
Zoon, Director, Center for Biologics Evaluation and Research).
\3\ Anthrax Vaccine Adverse Reactions, Hearing before the
Subcommittee on National Security, Veterans Affairs, and International
Relations, House Committee on Government Reform, 106th Cong., 1st sess.
(July 21, 1999) (testimony of Susan S. Ellenberg, Ph.D., Director,
Division of Biostatistics and Epidemiology, Center for Biologics
Evaluation and Research).
Our confidence in this vaccine, like all vaccines, is
based upon four components: first--the review of
manufacturing and clinical trials and subsequent
clinical laboratory experience with the vaccine;
second--ongoing inspections of the manufacturing
facility; third--our lot release requirements; and
fourth--our ongoing collection and analysis of adverse
event reports. So far, the data gathered from VAERS
reports on anthrax vaccine do not signal concerns about
the safety of the vaccine.\4\
---------------------------------------------------------------------------
\4\ Defense Vaccines: Force Protection of False Security? Hearing
before the House Committee on Government Reform, 106th Cong., 1st sess.
(Oct. 12, 1999) (testimony of Dr. Katherine Zoon, Director, Center for
Biologics Evaluation and Research).
Without additional information to the contrary, we are not
in a position to overturn FDA's judgment. Unlike FDA officials,
we have little or no medical expertise. In our opinion, the
report's criticism of a lack of studies demonstrating safety is
insufficient to overturn FDA's findings based on the vaccine's
30-year history.
In addition, we fear the report's expectations for the
safety of a new generation vaccine may be overly optimistic.
The report recommends that DOD suspend its program only until
it obtains ``approval for use of an improved vaccine.'' Yet the
recombinant vaccine envisioned by the report may be no safer
than the existing version. The report concedes that ``an
improved vaccine based on recombinant technology may not
necessarily have better safety characteristics than the current
vaccine,'' but it offers no further explanation.
We would encourage further safety research on a new anthrax
vaccine. In addition, we agree with the report's recommendation
to pursue testing of the safety and efficacy of a shorter
anthrax inoculation regimen. We also agree with the report's
emphasis on continued testing for intramuscular injections,
which may reduce reaction rates generally and address
proportionally higher reaction rates among women.
v. classification of the vaccine as ``experimental''
With respect to reclassification of the vaccine, we also
defer to FDA's opinion that DOD's current use of the anthrax
vaccine should not be considered ``experimental.'' On November
3, 1999, Representatives Burton, Shays, Gilman, and Jones wrote
to FDA essentially proposing the report's recommendation to
reclassify the vaccine as ``experimental'' and conduct
investigational new drug [IND] testing.\5\ The rationale for
this argument was that FDA had approved the vaccine for use
against ``cutaneous'' infection (through the skin) during
occupational use, but not against ``inhalation'' infection
(through the lungs) during wartime.
---------------------------------------------------------------------------
\5\ Letter from Representatives Burton, Shays, Gilman, and Jones to
Dr. Jane E. Henney (Nov. 3, 1999).
---------------------------------------------------------------------------
In a November 26, 1999, response, FDA found no basis for
this proposal.\6\ FDA corrected a misconception that the
vaccine is licensed only for use ``by a limited population of
individuals at risk for cutaneous exposure to anthrax.'' \7\
FDA also stated that ``use of the vaccine for protection
against both cutaneous and inhalation anthrax exposure is not
inconsistent with the labeling.'' \8\ Addressing the proposal
directly, FDA stated:
---------------------------------------------------------------------------
\6\ Letter from Melinda K. Plaisier to Representative Walter B.
Jones (Nov. 26, 1999).
\7\ Id. at 2.
\8\ Id.
There is presently no basis for concluding that the
anthrax vaccine, a licensed product, when used in
accordance with current labeling, should be used
pursuant to an IND application or, as requested in your
letter, that FDA ``place the anthrax vaccine back under
IND status.'' \9\
---------------------------------------------------------------------------
\9\ Id. at 3.
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vi. recommendation to suspend the program
Whether to suspend the vaccination program is a decision
that must be made by security experts based on the most
complete information relevant to all risks and benefits. These
factors are sometimes unquantifiable; indeed, some are
unknowable and will remain so until ultimately tested in
combat. Because the report is not based on classified
information regarding the likelihood of an anthrax attack, it
provides insufficient information to overturn DOD's decision to
pursue the vaccination program.
The report recognizes that ``[t]hreat assessment requires
objective and subjective analyses of U.S. vulnerabilities,
enemy capacity, and enemy intentions.'' The report also
acknowledges that ``much of the information regarding the BW
[biological weapons] capabilities and intentions of potential
adversaries, and even allies, is classified.'' Yet the report
bases its conclusions only on unclassified information. Members
received no classified information at the full committee level,
and the subcommittee had no closed hearings in which it could
consider such information.
As a result, the report's conclusions--that ``the threat
remains tactically limited and regional'' and that the program
``is designed to reach far beyond those at risk''--do not
reflect DOD's full judgment about the actual extent of the
threats involved. The report states that ``DOD has determined
the threat is real and imminent, and has concluded it would be
irresponsible not to deploy an available countermeasure to
protect the lives and fighting capability of U.S. forces.''
Without additional information to the contrary, we defer to
DOD's conclusion.
vii. kevin edwards
At the committee meeting to consider this report,
Representative Dan Burton, chairman of the Committee on
Government Reform, raised the case of Kevin Edwards. He began
his statement by displaying photographs of Mr. Edwards's
bruised body. He then said:
We have spoken to many individuals who have been ill
for a very, very long time. One example is Mr. Edwards
of North Carolina. I want you to look at these
pictures. I think these pictures will show what can
happen when there really is a bad reaction or an
adverse event. Mr. Edwards has what appears to be third
degree burns on much of his body but in fact, it is a
condition that developed after receiving the anthrax
vaccine.
Subsequent investigation by the minority does not
substantiate Mr. Burton's allegations. While Chairman Burton
attributed Mr. Edwards's illness to the anthrax vaccine, he
failed to disclose that Mr. Edwards's case had been considered
by the Anthrax Vaccine Expert Committee. Although the Privacy
Act protects Mr. Edwards's medical records, the findings of the
Expert Committee were fundamentally different from Chairman
Burton's conclusions.
Exhibit 1 to these views is a letter from Representative
Henry A. Waxman, ranking minority member, that sets forth
additional details related to Mr. Edwards's case.\10\
---------------------------------------------------------------------------
\10\ Letter from Representative Henry A. Waxman, ranking minority
member, to Representative Dan Burton, chairman (Mar. 17, 2000) (exhibit
1).
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Hon. Henry A. Waxman.
Hon. Rod R. Blagojevich.
Hon. Tom Lantos.
Hon. Major R. Owens.
Hon. Eleanor Holmes Norton.
Hon. Elijah E. Cummings.
Hon. Danny K. Davis.
Hon. John F. Tierney.
Hon. Harold E. Ford, Jr.
Hon. Janice D. Schakowsky.
SUPPLEMENTAL VIEWS OF HON. BERNARD SANDERS
The chairman of the Subcommittee on National Security,
Veterans Affairs, and International Relations is to be
commended for the extremely thorough hearings he has held
leading up to this report. He is also to be commended for the
extremely well documented report, itself, and the decisive
recommendations contained therein. All of these recommendations
are fully supported by the testimony presented to the
subcommittee--testimony which raised serious questions about
the anthrax vaccine, its manufacturer, and the Department of
Defense's [DOD] vaccination program.
As the report documents, the anthrax vaccine is of
questionable efficacy and safety. DOD's mishandling of the
vaccination program has exacerbated these concerns. Questions
about efficacy have been compounded by the failure of DOD to
administer the six shot regimen in accordance with the FDA-
approved vaccination schedule. Safety concerns have been
heightened by DOD's failure to track and record adverse
reactions. Moreover, DOD's refusal to even acknowledge the
concerns raised by members of the armed services has created
significant morale problems among active service members, as
well as National Guard and Reserve forces.
DOD also must shoulder the blame for failing to pursue a
more effective and safe vaccine against anthrax. Had DOD acted
immediately after the Persian Gulf war to find an alternative;
a safer, more effective vaccine would be available now.
Against this backdrop of DOD mismanagement and
stonewalling, some service members have refused to be
vaccinated against anthrax. As a result, service members have
been disciplined, including being discharged from the armed
services. While I fully understand the need for the military to
insist on compliance with lawful orders, DOD cannot escape its
own responsibility for the refusal of its members to take the
vaccine.
The subcommittee's report expressly ``makes no
recommendation regarding the status of those service members
who left the armed forces voluntarily, or as the result of
disciplinary action, due to the anthrax vaccine.'' Some have
questioned whether the order to take the vaccine itself is
lawful. The subcommittee did not set out to answer that
question and the testimony it received was not adequate to
resolve it.
DOD's position is buttressed by the Food and Drug
Administration's [FDA] view that DOD's anthrax program does not
represent an off-label use. However, given the documented
failure of DOD to administer the vaccine in accordance with the
FDA's approved schedule, DOD's insistence on deploying service
members before the six shot regimen is complete, and the
insufficiency of scientific evidence to support claims of
efficacy against weaponized anthrax, it is not clear that the
FDA's position would pass muster under the Administrative
Procedures Act's ``arbitrary, capricious or contrary to law''
standard.
This ambiguity and the well documented DOD mishandling of
its anthrax vaccine program argues strongly that, at a minimum,
DOD should exercise extreme leniency in its treatment of
service members who have refused to take the anthrax vaccine,
including removing derogatory findings and comments in service
records, reversing reductions in rank and pay, and permitting
the re-enlistment of members who have been discharged.
If DOD accepts the subcommittee's recommendation--as it
should--to recategorize its anthrax program as being in
Investigational New Drug status then future disciplinary
proceedings will be unnecessary because service members will
only receive the vaccine after providing their informed
consent.
If there is one thing that the subcommittee learned from
its review of DOD's anthrax vaccination program it is that the
trust of many service members has been severely shaken.
Acceptance of the recommendations in the subcommittee's report
and reversal of prior disciplinary actions will go a long way
toward rebuilding the trust of service members in the DOD and
would be in the best interest of our Nation's armed forces.
Hon. Bernard Sanders.